Our office has loaned out an enuresis alarm to a pt for treatment of primary nocturnal enuresis.The pt was a (b)(6) y/o girl diagnosed with autism.Parents were instructed on use of alarm.Alarm was new.Parents used alarm and reported burns to pt's skin within 30 mins of using the alarm.Pt was scared and no fault of pt.Alarm malfunctioned and caused injuries.The cause was likely a defect in alarm which caused it to overheat and short out the batteries.Parents claimed that the alarm had battery acid leak on the underside and was on high temperature.We reached out to the mfr for explanation several times, but have not received any response.Our observation is that the alarm is defective.Pt was asleep when incident occurred.No fault of parents or pt.Alarm was used correctly.Child has first degree burns on chest and being treated for shock and depression.Fda safety report id# (b)(4).
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