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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD. ULTIMATE BEDWETTING ALARM; ALARM, CONDITIONED, RESPONSE ENURESIS
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MALEM MEDICAL LTD. ULTIMATE BEDWETTING ALARM; ALARM, CONDITIONED, RESPONSE ENURESIS Back to Search Results
Model Number M042
Device Problems Patient-Device Incompatibility (2682); Temperature Problem (3022)
Patient Problems Irritation (1941); Burn, Thermal (2530)
Event Date 05/03/2019
Event Type  Injury  
Event Description
Been using the malem alarm for 2 weeks with no results.However my daughter has developed skin rash around the area that the alarm is touching her.It appeared that she had an allergic reaction to the plastic on the alarm, but after we visited the dr, they said that the issue is not that but the alarm defect.Dr demonstrated that by turning the alarm on and waiting 20 mins.The alarm got warm and remained warm for many mins.We then realized that the alarm was getting hot and that was burning her skin.She was asleep and did not realize it.However it was sufficient to cause skin irritation on her.There are small red patches on her skin from the burns.Dr has told us to discontinue using the alarm and report this matter to the fda.Skin irritation.Fda safety report id# (b)(4).
 
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Brand Name
ULTIMATE BEDWETTING ALARM
Type of Device
ALARM, CONDITIONED, RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD.
MDR Report Key8623992
MDR Text Key145676631
Report NumberMW5086742
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 05/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberM042
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age4 YR
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