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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL MALEM ULTIMATE BEDWETTING ALARM
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MALEM MEDICAL MALEM ULTIMATE BEDWETTING ALARM Back to Search Results
Device Problems Break (1069); Leak/Splash (1354); Overheating of Device (1437)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/04/2017
Event Type  Injury  
Event Description
It's shocking how a bedwetting alarm can malfunction and hurt a child.I switched from a wet-stop bedwetting alarm to a malem alarm because we kept breaking the sensor board.The malem alarm was purchased from bedwetting store website about 1 week ago.It arrived and i used it on my daughter.The alarm part uses batteries and the alarm part over-heated within 30 minutes of the batteries getting inserted.The batteries shorted out and the alarm unit got very hot.So hot that you could burn your fingers on if you touched it.I removed it and placed it on the side of the bed as my daughter was scared of the alarm and just as it sat on the table, the batteries leaked and spread on the table.It's scary to imagine what would have happened if the alarm was placed on my daughter's body.She was terrified and so am i.
 
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Brand Name
MALEM ULTIMATE BEDWETTING ALARM
Type of Device
MALEM ULTIMATE BEDWETTING ALARM
Manufacturer (Section D)
MALEM MEDICAL
MDR Report Key7148172
MDR Text Key95941276
Report NumberMW5074258
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 12/22/2017
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
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/26/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age4 YR
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