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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD. ULTIMATE PRO BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL LTD. ULTIMATE PRO BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Device Problems Melted (1385); Overheating of Device (1437); Smoking (1585)
Patient Problems Scarring (2061); Burn, Thermal (2530)
Event Date 09/10/2020
Event Type  Injury  
Event Description
A brand new malem alarm purchased from (b)(6) has malfunctioned the first time it was used.I inserted batteries that came with the alarm and as i was placing it on my son, it started to smell and i noticed fumes coming from the top of the alarm.The back side got so hot that it partially melted and fused to my sons shirt.He was laying in bed and the alarm scarred him partially on his neck.I was so scared that the alarm would catch fire or burst.I quickly made my son remove his shirt and threw it on the floor.After 30 minutes, the shirt was burnt and there was a big hole in the shirt where the alarm was connected.Also the alarm plastic melted and the device is not usable.Too dangerous and we are scared to try another device like this in the future.Fda safety report id# (b)(4).
 
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Brand Name
ULTIMATE PRO BEDWETTING ALARM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD.
MDR Report Key10540929
MDR Text Key207373066
Report NumberMW5096669
Device Sequence Number1
Product Code KPN
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 09/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age8 YR
Patient Weight31
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