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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD. ULTIMATE ALARM FOR BEDWETTING; ALARM, CONDITIONED RESPONSE ENURESIS

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MALEM MEDICAL LTD. ULTIMATE ALARM FOR BEDWETTING; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Model Number M04
Device Problems Overheating of Device (1437); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/18/2019
Event Type  Injury  
Event Description
The device has a low-quality appearance, but i thought it'd at least work.After a few days, it overheated when i tried to turn it on and made a burning noise.I worry if the overheating could have happened at night and hurt my son.The alarm device is cheaply manufactured.It lasted about 4 days for us before it overheated.The company admitted it was substandard but offered no replacement.Did not even take it back.
 
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Brand Name
ULTIMATE ALARM FOR BEDWETTING
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD.
MDR Report Key8470898
MDR Text Key140638236
Report NumberMW5085441
Device Sequence Number0
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 03/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2019
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model 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 Age5 YR
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