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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD. ULTIMATE BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL LTD. ULTIMATE BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Model Number ULTIMATE MODEL
Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425); Overheating of Device (1437); Electrical Shorting (2926)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/03/2019
Event Type  Injury  
Event Description
The alarm stopped working in less than 3 nights of use and appears to have short circuited.This happened after the alarm would not turn off until i removed the batteries.The result of the short was that the alarm would get very hot and my son would have to remove it.One night i decided to remove the batteries and let the alarm just sit on the tabletop.When i checked 45 mins later, there was burning smell in the room and there was slipper material on the alarm bottom (leaks from battery).I think the excess heat deformed the plastic case of the alarm.I was terrified and very disturbed with the alarm and its safety.Now, my son has regressed and is back to bedwetting all over again.We rather be safe than use an unstable product.Fda safety report id# (b)(4).
 
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Brand Name
ULTIMATE BEDWETTING ALARM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD.
MDR Report Key8777065
MDR Text Key150759351
Report NumberMW5087998
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 07/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2019
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberULTIMATE MODEL
Device Catalogue NumberM042
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 Age4 YR
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