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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 Premature Discharge of Battery (1057); Overheating of Device (1437)
Patient Problems Pain (1994); Burn, Thermal (2530); Superficial (First Degree) Burn (2685)
Event Date 03/11/2019
Event Type  Injury  
Event Description
I purchased a bedwetting alarm for my daughter from online and received it on (b)(6).On that night, i set up the device on her and put her to bed.I tested it and it seemed to work properly.However, my daughter was in pain and screaming bout 45 mins later and she said the alarm was burning her.It seemed impossible, but when i looked closely, i noticed that the alarm was too hot and it had burnt a hole in her shirt.I immediately helped her and we removed her shirt at night.The alarm was hot and on checking back after an hour, it had cooled down and batteries were dead.My daughter suffered a nighttime scare and blisters on her skin from the alarm.It isn't serious, but nevertheless, she was injured from using the device.
 
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Brand Name
MALEM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD.
MDR Report Key8432781
MDR Text Key139345849
Report NumberMW5085003
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 03/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberM04
Device Catalogue NumberM04
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 Age6 YR
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