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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM BED WETTING DEVICE; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL LTD. MALEM BED WETTING DEVICE; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Catalog Number M04-BLUE
Device Problems Leak/Splash (1354); Overheating of Device (1437)
Patient Problems Swelling (2091); Burn, Thermal (2530)
Event Date 02/25/2019
Event Type  Injury  
Event Description
Last night, my son was injured and suffered minor burns on his skin.He was using the malem bedwetting alarm which we purchased for him.The alarm has a moisture detection part which i clipped on the outside of his underwear and the alarm part which i placed on his t-shirt top near his neck.I put him to sleep and he came running into my room holding the t-shirt away from his body.He is (b)(6) and was unable to remove the alarm on his own.I asked him why and he screamed in pain.I tried removing the alarm, but the process burnt my fingers.The alarm was hot like coal.I pulled off his t-shirt and checked on him.He had a bright red burn mark like a blister on his skin.The alarm wrapped up in the t-shirt made a hole in the shirt and then there was gray powder that spilled out from it.That was possibly the batteries spilling out from the product.I have treated my son at the pediatricians office.
 
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Brand Name
MALEM BED WETTING DEVICE
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD.
MDR Report Key8379035
MDR Text Key137443306
Report NumberMW5084511
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 02/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberM04-BLUE
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age4 YR
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