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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL LTD BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Model Number M04
Device Problems Overheating of Device (1437); Explosion (4006)
Patient Problems Pain (1994); Burn, Thermal (2530)
Event Date 06/14/2019
Event Type  Injury  
Event Description
Did nothing unusual.The alarm was used as directed.Simple setup.Place batteries in the alarm and connect sensor.Then place sensor on underwear and child sleeps.Once urine is detected, alarm strips and wakes up everyone.This however did not happen in our case.The new alarm exploded at night under normal use and batteries onto my daughter's skin.The alarm was very hot.She was in pain and crying out loudly when this happened.By the time i pulled out the alarm from her t-shirt, she was already partially burnt from the hot alarm.The alarm burnt out on its own and stopped working after causing significant mental stress and scare for our family.I was able to treat her burns at home without need to visit the hosp.She is frightened and refuses to get treatment for her bedwetting.Fda safety report id# (b)(4).
 
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Brand Name
BEDWETTING ALARM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD
MDR Report Key8758828
MDR Text Key150157658
Report NumberMW5087824
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 07/01/2019
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 NumberM04
Device Catalogue NumberULTIMATE
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/02/2019
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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