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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 Problems Melted (1385); Device Emits Odor (1425); Overheating of Device (1437)
Patient Problem Burn, Thermal (2530)
Event Date 02/27/2019
Event Type  Injury  
Event Description
We have twins and both are bedwetters.We purchased two alarms and our children started using them.One of our boys was hurt at night from the alarm malfunction.We were sleeping when our son was howling and crying in pain.When i woke up, i heard the alarm buzzing and my son crying.When i ran to his room, he complained that he was burning from the alarm.Since this alarm was attached on his shirt, he was not able to remove it on his own.I also felt it extremely hot when i removed it.Hard to removed such a hot device.Finally, after removing it, i kept it aside.It was smelling like burning plastic and the heat had caused the back plastic to partially melt.We rushed our son to the clinic for treatment of burns.The other alarm our other son was using was not hot, but warm.We removed it too and stopped using the alarm for our children.
 
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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 Key8388143
MDR Text Key137871799
Report NumberMW5084606
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 03/01/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received03/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age4 YR
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