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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD BED WETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL LTD BED WETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Model Number M04
Device Problems Circuit Failure (1089); Temperature Problem (3022)
Patient Problems Burn(s) (1757); Pain (1994)
Event Date 03/10/2019
Event Type  Injury  
Event Description
Daughter was sleeping in her bed at night and the bed wetting alarm connected on her.The alarm was placed on her shirt near neck and the sensor plugged outside undies.The alarm detected urine and alerted my daughter, but she did not wake up to the alarm.I was sleeping in the other room and heard the alarm.I waited for my daughter to wake up but she did not.After 25 mins, i went to her room to wake her up.I noticed that the alarm had scarred her skin from heat.I immediately removed the alarm and addressed the problem.I used neosporin for the burns and pain.The alarm was on the side of the bed and it stopped heating up.Now it won't turn on as it has short circuited and the batteries leaked inside the alarm.The alarm is useless now and it has hurt my child.We suffered a scare at night.The alarm is made from plastic which is bent from excess heat.
 
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Brand Name
BED WETTING ALARM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD
MDR Report Key8424859
MDR Text Key139098257
Report NumberMW5084933
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 03/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Age5 YR
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