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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 M04
Device Problems Leak/Splash (1354); Temperature Problem (3022); Noise, Audible (3273)
Patient Problem Burn, Thermal (2530)
Event Date 03/02/2019
Event Type  Injury  
Event Description
Last night was the first time my son used a malem alarm and we had a frightful experience.Prior to using the alarm, i watched online videos and read the user manual.I set it up on my son before he went to bed and let him sleep.But he was screaming for help only 30 minutes later tugging the shirt away from his body.I asked him and he said the alarm was hot and burning him.At first, it seemed impossible as it is battery operated, but i soon saw it myself.The alarm was smelling bad too.I removed it with difficulty and treated my son.When i checked back, the alarm had stopped working and leaked batteries.My son suffered a scare.Fortunately, he was not injured.
 
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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 Key8394107
MDR Text Key137995168
Report NumberMW5084661
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 03/03/2019
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
Device Model NumberM04
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/05/2019
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age3 YR
Patient Weight32
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