BOX 4.1
Excerpts from Examples of Reports Involving Children in FDA Adverse Event Databasea

Device: Circumcision clamp

FDA Device Classification: Clamp, circumcision

Problem Description

Circumcision using [circumcision] clamp. Clamp was loose, resulting in laceration of the glans penis with loss of tip. Infant was transferred to another hosp for urologic consultation and surgery to repair damaged penis. (MAUDE Report No. 257649)

Device: Vacuum extractor

FDA Device Classification: Extractor, vacuum, fetal

Problem Description

Infant boy was delivered at [time] on [date]. Delivery was complicated by a prolonged second stage. Infant suffered hemorrhage beneath scalp at birth. Infant was admitted to neonatal intensive care unit and was placed on ventilator at [time]. Infant expired at [time] on [date]. The cause of death was the hemorrhage. It is speculated that the hemorrhage resulted from the use of a vacuum extractor with a defective gauge. Gauge on the device registered in the green “safe” zone even though excess vacuum was being produced. This defect was confirmed by testing the device using a pressure transducer. There would have been no way the user of the device would have known that the gauge was defective and that a dangerous level of vacuum was being produced … Device manufacture date is 1/17/96. (MDR Access No. M763107)

Device: Nasal dressing

FDA Device Classification: Bandage, liquid

Problem Description

The nasal dressing was placed in the pt in 2004 subsequent to sinus surgery. Two days later the nasal dressing fell apart while trying to remove it. The hosp health professional tried to remove the dressing again in 2004 and was unable to do so. The next day the dressing was surgically removed.

Manufacturer Response

User was not able to provide lot number, therefore mfg data is unavailable. The device did not fail, but was apparently cut or teased apart in an attempt to remove it. Surgically removed sample showed the pvc pouch with foam inside was fully intact, three weeks following initial surgery; indicating that the core of the product did not come apart; but was wedged and had to be surgically removed. User selected a 3 cm adult size contributing to the difficulty of removal. More suitable choices, when dealing with a small child’s anatomy, include: the smaller removable dressing; model rr 200 which is 1/3 smaller than the device used. The dissolvable dressing; commonly used for pediatric cases because they can be trimmed to fit any size/shape anatomy, and do not require physical removal. (They dissolve away over time.) (MAUDE Report No. 1064611-2004-00002)

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