The intent of the report is to report three similar incidents which resulted in children getting injured at night in their sleep while using the malem bed wetting alarm device.The three incidents took place on (b)(6) 2019, (b)(6) 2019 and (b)(6) 2019.The age of the user was (b)(6) years in two cases and (b)(6) years in the other case, in each case, the malem alarm was purchased new from the mfr's website and used only for 1 night.The alarm overheated at night when the child was sleeping.The alarm has burnt the child's skin when they were asleep.We have discontinued recommending this alarm to pts.The alarms have been returned back to mfr for inspection.The cause of the failure is likely an electrical short that caused the device to generate excess heat and leak batteries which spread on the child's body.The children were treated for first degree burns and discharged.A new bed wetting alarm was recommended, but parents have decided not to continue treatment.Ref report numbers: mw5086096 and mw5086116.Fda safety report id# (b)(4).
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