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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 ULTIMATE BEDWETTING ALARM
Device Problems Overheating of Device (1437); Defective Component (2292); Electrical Shorting (2926); Failure to Shut Off (2939)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/26/2019
Event Type  Injury  
Event Description
The alarm stopped working about 2 days later and appears to have short circuit.This happened after the alarm would not turn off until i removed the batteries.Now, when i reinsert the batteries and the cable.It is getting hot and burning from the inside.Pungent smell like burning plastic coming from the inside of the alarm unit.The defect goes when the cable is removed and alarm comes back to normal temperature in 15 mins.But when it's hot, it's just too hot.I can't hold and certainly can't place it on my son.Now, my son refuses to try another product for bedwetting and we are both worried of possible burns from this type of device.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 Key8790639
MDR Text Key151172185
Report NumberMW5088097
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 07/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberULTIMATE BEDWETTING ALARM
Device Catalogue NumberM043
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 Age6 YR
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