A Lethal Pacifier

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PEDIATRICS Vol. 58 No. 6 December 1976 853

EXPERIENCE

AND

REASON-Briefly

Recorded

“In Medicine one must pay attention not to plausible theorizing but to experience and reason

together. . . .I agree that theorizing is to be approved, provided that it is based on facts,

and systematically makes its deductions from what is observed. .. .But conclusions drawn from unaided reason can hardly be serviceable; only those drawn from observed fact.”

Hippocrates: Precepts. (Short communications offactual material are published here. Comments and criticisms appear as Letters to the Editor.)

A Lethal

Pacifier

A 5-month-old boy died of asphyxia from

airway obstruction caused by his pacifier. It had been imported from Spain by La Cibeles Inc. of Union City, New Jersey, and had been marketed in New York, Massachusetts, New Jersey, Connecticut, Illinois, Maryland, Florida, and Puerto Rico under the brand names Fauna, Flower, Navy, and Texas. It sold for about 50 cents. It is attractive in design, but has character-istics that make it dangerous. Following our report to the United States Consumer Product

Safety the pacifier was recalled.

We have been able to find only one similar case in

the literature.’ The unnecessary tragedy was due to a preventable hazard and both individual and governmental action should avoid its

recur-rence.

CASE REPORT

W.B., a healthy, 5-month-old boy was sitting in his high

chair while his mother prepared the evening meal in the

same room. He was sucking his pacifier (Fig. 1). While his mother’s back was turned, she suddenly heard a gasping

sound and turned around to notice him choking on his

0U.S. Consumer Product Safety Commission, Washington,

D.C. 20207 (telephone, 800-638-2666; Maryland,

800-492-2937).

pacifier. She tried to pull it from the back of his mouth but

was unable to get it out. She ran frantically with the baby to

her next door neighbor who, inexplicably at the time, also

failed in the attempt to remove it. The baby was still

struggling to breathe and the father, the police, and an ambulance were called to the house. After several more

attempts they were still unable to remove the pacifier,

although they were able to grasp it between tluimb and

forefinger. Attempts to remove it seemed to push it further in, rather than out. Pounding on the back also did not help. The police officers started mouth to mouth ventilation with

external cardiac massage and took the baby to the emer-gency room of the Montefiore Hospital and Medical Center.

On arrival he was “clinically dead.” On direct larngos-copy, the mouse’s head-shaped portion of the pacifier was

observed in the back of the baby’s mouth and an attempt to remove it with forceps wa.s unsuccessful. Finally, the resident

physician was able to 1oop her fingers around the “neck” of

the “mouse” and by exerting an extraordinary amount of

force was able to extract the rubber portion of the pacifier by forcing the nipple through the center hole in the plastic

flange of the pacifier (Fig. 2). Unknown at the time, the

plastic flange still remained wedged in the hpopharnx, but

the hole in the flange allowed enough air passage to permit bag-and-mask ventilation. With the restoration of ventila-tion, external cardiac massage and other resuscitative

measures restored circulation with return of a heart beat.

Apnea was estimated at 20 minutes and cardiac arrest had

lasted at least six minutes. When endotracheal intuhation was then attempted, the plastic flange was discovered still in

the hypopharynx and was easily removed.

The patient was then admitted to the Montefiore Pediatric

Special Care Unit and maintained on a respirator. He died

six days after admission without regaining consciousness and

with clinical brain death.

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DISCUSSION

We found only three other deaths due to

pacifiers in the literature.’2 Two were due to strangulation when a ribbon, in one case, and a shoestring, in the other, were tied to the pacifier,

placed around the baby’s neck and became

entangled. In the third case,’ which was similar to ours, a baby was found dead after having

aspi-rated his entire pacifier which was wedged in his mouth. The rigid plastic flange of that pacifier was only 31 mm in diameter, The “safer”

pacifi-ers have flanges that are at least 44 mm in

diameter.

The justifications and indications for the use of

a pacifier remain open to debate3 and will not be discussed here. Nevertheless, there is no reason, if one wishes to use a pacifier, to take a potentially lethal risk. Safe pacifiers are available. They have large, flat flanges, are of solid, one-piece construe-tion, are made of sturdy, nontoxie materials, and have an easily grasped handle (Fig. 3). The pacifier shown in Figures 1 and 2 has few of these characteristics. Instead, while deceptively attrac-tive, it is inherently dangerous in design. It comes in three pieces (Fig. 2)-the cute animal head made of rubber, the flexible plastic flange, and the rubber nipple. The plastic flange is shaped like a saucer with a hole in the bottom. Its widest diameter is 38 mm and the hole is 8 mm in

FIG. 1. Anterior view of the lethal pacifier.

FIG. 2. The three component parts of the lethal pacifier. The plastic flange is in the center.

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EXPERIENCE AND REASON 855

Fi;. 3. A safe pacifier.

diameter. When in use, the bottom end of the saucer, the narrower end of the flange, faces the

nipple and contacts the lips. Because the flange is too small and quite flexible, it is possible to push

in into the baby’s mouth. Once in the soft tissues of the pharynx, it tends to reexpand due to its inherent elasticity which would be exaggerated when pulled on from the center. It actually looks

very much like a mushroom anchor. It can be

moved readily in only one direction, further in, until the passageways get too narrow for further movement, thus blocking the airway.

Not all the pacifiers have animal “heads.” Some have sailor “heads,” some a cowboy, and others have no “head.” There are no identifying marks on the pacifier except for “Made in Spain”

in relief on the flange. The cnicial defect is the

small, flexible plastic flange. All pacifiers with such a flange regardless of manufacturer or

anything else should be destroyed.

The recall effort has been relatively ineffective

because of incomplete records by those involved in the sale of the pacifiers. It was estimated that over 150,000 of the pacifiers had been distributed and many are still in use.

Parents, physicians, and governmental agencies have a role to play in preventing such accidents. Parents should learn that small objects should be kept away from small babies. Physicians should include such counsel as part of routine well-child care. The consumer product safety act (Public Law 92-573; 15 U.S.C. 2051, et seq.) which established the U.S. Consumer Product Safety

Commission appears to have given the

Commis-sion adequate power to deal with such hazardous

products, not only to recall, but also to prevent importation, manufacture, distribution, or retail

sale of consumer products that do not meet safety standards. The commission is empowered to

conduct investigations, testing, and research and

to set safety standards. There are criminal penal-ties of up to one year’s imprisonment and/or a

$50,000 fine for knowingly and willfully violating the act and there are also civil penalties.

Sixty-four million dollars was appropriated to carry out the legislation for the fiscal year ending June 30,

1975. The governmental mechanisms exist for

making this a safer world for children, as well as for adults. These mechanisms can be set in motion by reporting suspected hazardous products.

RICHARD E. KRAVATH, M.D.

Department of Pediatrics,

Monteflore Hospital

and Medical Center,

Albert Einstein College

of Medicine 1 1 1 East 21 0th Street

Bronx, New York 10467

REFERENCES

1. Mikalakis I: Asphyxia from pacifier. Md State Med J

20:53, 1971.

2. DiMaio VJM: Accidental hangings due to pacifiers. JAMA 226:790, 1973.

3. Gersh M: Pacifiers, or, a sticker is born every minute. In,

How To Raise Children at Home in Your Spare

Time. New York, Fawcett Publications, 1966, pp

62-63.

ACKNOWLEDGMENT

I wish to thank Mr. Louis Ardois and Mr. Jeffrey Simon,

Consumer Safety Officers in the New York area of the United States Consumer Product Safety Commission, for their considerate and efficient investigation that led to the recall of the pacifier.

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1976;58;853

Pediatrics

Richard E. Kravath