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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL LTD. MALEM; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Model Number M04
Device Problems Overheating of Device (1437); Defective Component (2292)
Patient Problems Rash (2033); Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)
Event Date 02/11/2019
Event Type  Injury  
Event Description
After just 1 night of use, my son has developed rash on his skin and neck.There was no rash prior to using the alarm.He has bedwetting alarm that he used at night and wore regular clothes.The alarm was placed as one would have and operated at night.My son went to sleep at 9:00 pm and we checked up on him at midnight and everything was alright.The alarm detected urine at 6:15 am and started beeping.I went in to check on him and he was in a pool of urine but the alarm was hot.It was beeping but not vibrating.The alarm was too hot to remove and my son had a blister on his neck from the skin contact.I pulled out the alarm from him and it burnt my fingertips.My son has stopped using the alarm and he has been given home treatment for the burns and blisters.
 
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Brand Name
MALEM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD.
MDR Report Key8350692
MDR Text Key136509123
Report NumberMW5084156
Device Sequence Number1
Product Code KPN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 02/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Lay User/Patient
Device Model NumberM04
Device Catalogue NumberBLUE
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/19/2019
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age6 YR
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