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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM; MALEM ALARM
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MALEM MEDICAL LTD. MALEM; MALEM ALARM Back to Search Results
Device Problems Material Disintegration (1177); Leak/Splash (1354); Temperature Problem (3022)
Patient Problem Burn, Thermal (2530)
Event Date 09/04/2016
Event Type  Injury  
Event Description
I purchased a malem alarm on (b)(6) 2016 from the bedwetting store website and started using it for my daughter in mid (b)(6).She used the alarm for a few weeks and one night, i set up the alarm and set it on the table.We had dinner and when i returned, there was gray/white liquid around the alarm.I picked it up but it was very hot.The back of the alarm had disintegrated and parts of it were stuck on the table.The batteries had leaked.There were brand new (b)(6) batteries we had just purchased, not the ones that came with the alarm.I burnt my finger lifting the alarm from the table.It was extremely hot and i couldn't touch it.I am glad that my daughter didn't wear it that night.Fortunately, my child didn't suffer any burns.I called the company.They refused to entertain me.The product was purchased from bedwetting store (b)(6).I can provide the product for analysis.(b)(6).
 
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Brand Name
MALEM
Type of Device
MALEM ALARM
Manufacturer (Section D)
MALEM MEDICAL LTD.
MDR Report Key6492974
MDR Text Key72899217
Report NumberMW5069073
Device Sequence Number1
Product Code KPN
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 04/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age5 YR
Patient Weight24
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