MALEM BEDWETTING ALARM

Description of Event or Problem

PATIENT IS A (B)(6) YEAR OLD MALE CHILD WHO WETS THE BED. PARENTS PURCHASED BEDWETTING ALARM FROM (B)(6) WEBSITE. THE ALARM HAD MALFUNCTION CAUSING INJURIES AND BURNS TO CHILD. CHILD WAS ADMITTED TO ER FOR BURNS (MINOR BUT SPREAD ON NECK). THE ALARM FAILED DUE TO DEFECT IN SHORT CIRCUIT ELECTRICAL PART. IT IS BELIEVED AS THE BATTERY HOLDER BENT FROM HEAT AND BATTERIES LEAKED ON CHILD'S CLOTHING AND ALL OVER THE ALARM. FDA SAFETY REPORT ID# (B)(4).