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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
Device Problem Overheating of Device (1437)
Patient Problems Scarring (2061); Burn, Thermal (2530)
Event Date 01/07/2019
Event Type  Injury  
Event Description
This is the second time our malem alarm has had a defect.The first one was about 4 months ago when son was using the alarm.At that time, it kept getting hot every time it detected urine.So i simply returned it for an exchange which worked partially.Now, we purchased a second malem alarm and the same thing is happening all over again.As soon as it detects urine, the alarm starts going from room temperature to warm to hot to very hot.This is happening to the outside surface of the alarm which has injured my daughter.The alarm touches her skin and the heat has scarred her a little bit.It's like a hot iron rod was placed on her neck while she was asleep.She was able to remove the alarm and place it on the side before any further serious incident occurred.Once the urine cable is pulled out, the alarm turns off.
 
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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 Key8239510
MDR Text Key133240784
Report NumberMW5083048
Device Sequence Number2
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 01/08/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/10/2019
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age9 YR
Patient Weight28
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