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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM ULTIMATE BEDWETTING ALARM; ALARM CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL LTD. MALEM ULTIMATE BEDWETTING ALARM; ALARM CONDITIONED RESPONSE ENURESIS Back to Search Results
Model Number M043
Device Problem Temperature Problem (3022)
Patient Problems Erythema (1840); Pain (1994); Burn, Thermal (2530)
Event Date 05/14/2019
Event Type  Injury  
Event Description
My wife set up the enuresis alarm for helping my daughter overcome bedwetting, but the device has done damage to him instead of helping him.The alarm likely short circuited at night when she was using it and asleep.As a result, the alarm burnt her skin on contact and she was in a lot of pain.The area is about 1 sq inch where the alarm was touching her and it was red when we checked.It was not very serious, but enough for us to report this to the dr's office and to the fda.We have discontinued the use of the product as if appears to be dangerous.The only way we could cool it down was to remove batteries.Other than that, it's a hot unstable device.Fda safety report id# (b)(4).
 
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Brand Name
MALEM ULTIMATE BEDWETTING ALARM
Type of Device
ALARM CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD.
MDR Report Key8632045
MDR Text Key145967477
Report NumberMW5086812
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 05/17/2019
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 NumberM043
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/21/2019
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age4 YR
Patient Weight17
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