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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL CORP. MALEM BED WETTING ALARM DEVICE
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MALEM MEDICAL CORP. MALEM BED WETTING ALARM DEVICE Back to Search Results
Model Number M04S
Device Problem Overheating of Device (1437)
Patient Problem No Code Available (3191)
Event Date 11/21/2017
Event Type  malfunction  
Event Description
Just now, i placed the malem alarm on my daughter as she was ready to go to bed.The batteries were inserted in correctly and the alarm was set up exactly as per the user manual.We even saw an instruction video online on how to correctly set up the system.I placed batteries in the system and placed it on my daughter with the correct setting.She complained that it was warm and then started to complain more that it was getting hot.She took it off and i noticed that as a few minutes passed by, the system kept getting hotter and hotter till it was so hot i could not hold it.I removed batteries from the alarm and set it aside and about 30 minutes later reinserted batteries.The same thing happened.I then tried with another set of batteries and once again the same thing.This alarm has a problem with overheating.If i could not hold it in my hand, i can't imagine how my daughter would wear it on her neck!.
 
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Brand Name
MALEM BED WETTING ALARM DEVICE
Type of Device
MALEM BED WETTING ALARM DEVICE
Manufacturer (Section D)
MALEM MEDICAL CORP.
MDR Report Key7057359
MDR Text Key92979027
Report NumberMW5073526
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 Other
Type of Report Initial
Report Date 11/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberM04S
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/24/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age12 YR
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