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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM ULTIMATE BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL LTD. MALEM ULTIMATE BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Model Number ULTIMATE
Device Problems Thermal Decomposition of Device (1071); Degraded (1153); Leak/Splash (1354); No Audible Prompt/Feedback (2282); Material Deformation (2976)
Patient Problem Burn, Thermal (2530)
Event Date 06/11/2019
Event Type  Injury  
Event Description
We've been barely using this for two hours / week and the batteries got rusty inside the device and leaked out.The alarm was super hot from the outside and i was unable to hold.My son was hurt rather badly.Heat has changed the shape of the alarm as well.The sound stopped working and vibration isn't working either now.I tried replacing the batteries but the alarm is burnt now.I am attaching a photo as well that shows the battery leak and the damage alarm.My son was so scared and worried.His neck was burnt from the heat.Bad and highly unsafe.Do you have a picture the product? yes.Fda safety report id# (b)(4).
 
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Brand Name
MALEM ULTIMATE BEDWETTING ALARM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD.
MDR Report Key8735404
MDR Text Key149424028
Report NumberMW5087624
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 06/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberULTIMATE
Device Catalogue NumberBLUE COLOR
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age6 YR
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