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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL UK BED WETTING DEVICE; ENURESIS ALARM
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MALEM MEDICAL UK BED WETTING DEVICE; ENURESIS ALARM Back to Search Results
Model Number M04
Device Problems Leak/Splash (1354); Melted (1385); Overheating of Device (1437); Product Quality Problem (1506); Defective Component (2292); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/05/2017
Event Type  malfunction  
Event Description
The product was purchased directly from (b)(6).It was recommended by a pediatrician so my daughter could stop wetting the bed.Received the product on monday and put in batteries on monday night.The batteries were inserted correctly, just like the instructions say.The device got warm to the touch and extremely hot within 15 minutes.It was so hot that i could not even hold it.Before we could even remove the batteries from the alarm unit, they leaked out and spilled on to the table where it was placed.My daughter is very scared of using another alarm like this one.The heat has caused the back casing of the product to partially melt.The alarm is not safe for use.This is definitely poor workmanship and a product defect.
 
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Brand Name
BED WETTING DEVICE
Type of Device
ENURESIS ALARM
Manufacturer (Section D)
MALEM MEDICAL UK
MDR Report Key7027281
MDR Text Key92059754
Report NumberMW5073263
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 11/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
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 Age6 YR
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