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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL MALEM ENURESIS ALARM; BED WETTING ALARM
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MALEM MEDICAL MALEM ENURESIS ALARM; BED WETTING ALARM Back to Search Results
Model Number MO4S2
Device Problems Leak/Splash (1354); Overheating of Device (1437); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)
Patient Problem Burn(s) (1757)
Event Date 02/02/2016
Event Type  Injury  
Event Description
The cable on the product stripped off and started to shock the user at night.User then taped the cable which any normal parent would do and the unit malfunctioned.It overheated and batteries leaked out at night causing the product to seriously harm the child using the product.Under normal circumstances, the product should have stopped working.Overheating and batery leaks are dangerous and child has suffered burn marks below the neck.Dates of use: (b)(6) 2016.Diagnosis or reason for use: child has primary nocturnal enuresis.
 
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Brand Name
MALEM ENURESIS ALARM
Type of Device
BED WETTING ALARM
Manufacturer (Section D)
MALEM MEDICAL
fulton MD 20759
MDR Report Key5447929
MDR Text Key38693816
Report NumberMW5060294
Device Sequence Number1
Product Code KPN
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Attorney
Type of Report Initial
Report Date 02/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberMO4S2
Device Lot NumberM04S2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/04/2016
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/16/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age6 YR
Patient Weight26
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