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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD. ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL LTD. ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Model Number ULTIMATE PRO 8 TONE
Device Problems Device Emits Odor (1425); Overheating of Device (1437)
Patient Problem Burn(s) (1757)
Event Date 12/09/2019
Event Type  Injury  
Event Description
Malfunction in the bedwetting alarm caused to overheat and the temperature went way beyond normal range i think.The alarm was super hot and appeared to be smelling of pungent odor of burning plastic.Daughter woke up immediately and yanked the alarm off from clothing, but it was a bit late.She suffered burn marks on her neck and skin.What is strange is that it seemed to work normally when i set it up on her.The alarm was functioning jut fine.It was when i plugged in the sensor that it started making clicking noises but i didn't think much of it and set it up anyway.Fortunately daughter was not fast sleep or the alarm would have injured her further.I had to take out batteries and leave it outside the home for fear it would catch fire.Fda safety report id# (b)(4).
 
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Brand Name
ALARM, CONDITIONED RESPONSE ENURESIS
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD.
MDR Report Key9491244
MDR Text Key172026638
Report NumberMW5091743
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 12/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberULTIMATE PRO 8 TONE
Device Catalogue NumberGOLD COLOR
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age8 YR
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