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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 ENDURESIS
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MALEM MEDICAL LTD MALEM ULTIMATE BEDWETTING ALARM; ALARM CONDITIONED RESPONSE ENDURESIS Back to Search Results
Model Number M04
Device Problems Display or Visual Feedback Problem (1184); Material Rupture (1546); Temperature Problem (3022)
Patient Problems Pain (1994); Burn, Thermal (2530)
Event Date 02/20/2019
Event Type  Injury  
Event Description
My daughter has been wetting the bed frequently and we purchased a bedwetting alarm from an online website.The alarm was to train her to stop bedwetting over time.However, this alarm has had a detrimental impact on my daughter.First, it does not work and second, its not safe to use.Instructions said that we needed to use it with batteries and there is a sensor that goes into the bottom of the alarm.However, when both are done, the alarm makes a short pulsed vibration.It is clear that something is stuck inside the alarm.I ignored this and put it on my daughter when she went to bed.Thirty minutes later, i could hear her screaming in pain and crying loudly.On checking, i noticed that the alarm had stopped working.The batteries had exploded inside the alarm and it was hot; very hot.When my daughter removed the alarm, she had to pull it out fast and her fingers were burnt from the hot alarm.We treated her at home and have stopped using the alarm for safety reasons.
 
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Brand Name
MALEM ULTIMATE BEDWETTING ALARM
Type of Device
ALARM CONDITIONED RESPONSE ENDURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD
MDR Report Key8371099
MDR Text Key137404038
Report NumberMW5084356
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 02/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberM04
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 Age9 YR
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