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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD MALEM ALARM ; ALARM, CONDITIONED RESPONSE ENURESIS

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MALEM MEDICAL LTD MALEM ALARM ; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Model Number ULTIMATE
Device Problems Device Emits Odor (1425); Overheating of Device (1437)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/12/2019
Event Type  Injury  
Event Description
The alarm clearly has an electrical problem.The alarm gets hot like there is an electrical short in it and within 30 mins, is untouchable.I am lucky that i put batteries and set it aside before i could put it on my daughter.It would be very harmful.The temperature on the outside of the alarm can easily be over 150f.So hot, i tried to replace the batteries, but same thing is happening.Also, there is burning plastic smell from the alarm.Completely unreliable and dangerous.Fda safety report id# (b)(4).
 
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Brand Name
MALEM ALARM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD
MDR Report Key9197069
MDR Text Key162681568
Report NumberMW5090404
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 10/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberULTIMATE
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/15/2019
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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