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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD MALEM BED WETTING DEVICE; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL LTD MALEM BED WETTING DEVICE; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Model Number M04S
Device Problems Overheating of Device (1437); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 02/24/2018
Event Type  Injury  
Event Description
I have noticed an issue with the bed wetting alarm which we just bought for our son.The alarm portion is getting hot as soon as batteries are placed inside and the wire is connected to the alarm portion.This is not normal.The alarm portion will start to make a clicking sound like something is stuck inside and then gets warmer and warmer till it gets hot.I have tried at least 4 different pairs of batteries but each time the result is the same.It is possible that we got a defective product, but it makes no sense that a brand new product which is just 1 day old should behave like this.My son has not worn the product, and we will be returning it.
 
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Brand Name
MALEM BED WETTING DEVICE
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD
MDR Report Key7302288
MDR Text Key101257648
Report NumberMW5075550
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 02/25/2018
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 NumberM04S
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/27/2018
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age7 YR
Patient Weight23
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