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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL MALEM BEDWETTING ALARM; ALARM, ENURESIS
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MALEM MEDICAL MALEM BEDWETTING ALARM; ALARM, ENURESIS Back to Search Results
Device Problem Melted (1385)
Patient Problems Burn(s) (1757); Pain (1994)
Event Type  Injury  
Event Description
I was always under the assumption that any medical device sold for children in the us is fda approved and safe.But i now think that the fda is either not concerned or has no time to check junk products like the malem bedwetting alarm.This product is so poorly built that it could have caused life threatening danger to my child.I bought the malem alarm for my son who has bedwetting problems as it has positive reviews on the site (b)(6).Two nights the alarm worked properly but on the third night of use i heard a loud scream.I had to rush to my son's room and found him screaming and crying.He showed me his neck which had a huge burn mark.The alarm was thrown on the ground and i noticed that the plastic door had melted.I had to rush him to the emergency room which ruined my full night there with my son who was going through a hell lot of pain.My questions to the fda: are children safe in this country? is the fda going to perform their due diligence on the malem alarm? why are junk products like the malem alarm allowed to play with children's lives? is the fda going to do anything or just relax till they get worse news from another child.
 
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Brand Name
MALEM BEDWETTING ALARM
Type of Device
ALARM, ENURESIS
Manufacturer (Section D)
MALEM MEDICAL
MDR Report Key6685798
MDR Text Key79134451
Report NumberMW5070777
Device Sequence Number1
Product Code KPN
Combination Product (y/n)N
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 06/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator No Information
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/30/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening;
Patient Age45 YR
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