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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM BEDWETTING ALARM ; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL LTD. MALEM BEDWETTING ALARM ; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Model Number M034 - YELLOW 8 RANDOM TONE
Device Problem Temperature Problem (3022)
Patient Problem Burn, Thermal (2530)
Event Date 04/08/2019
Event Type  Injury  
Event Description
I am not certain what caused the problem, but the enuresis alarm has seriously injured my daughter (age (b)(6)).She was wearing the alarm and went to bed at 8pm.She was in tears crying out at 8:45pm.I rushed in to check on her and saw that the bedwetting alarm had scarred her in the neck area.This is the first time the alarm was used and it was a new alarm purchased from the mfr (malemmedical.Com).My daughter was too young to remove the alarm on her own and the delay in removing the alarm from her caused the burns.The alarm is completely non-functional at this time.It will not operate as the internal electronics have likely burnt out.Fda safety report id# (b)(4).
 
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Brand Name
MALEM BEDWETTING ALARM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD.
MDR Report Key8531461
MDR Text Key142619304
Report NumberMW5085989
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 04/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberM034 - YELLOW 8 RANDOM TONE
Device Catalogue NumberM034 - YELLOW 8 RANDOM TONE
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/18/2019
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age4 YR
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