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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL MALEM BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL MALEM BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Device Problems Leak/Splash (1354); Melted (1385); Overheating of Device (1437); Device Displays Incorrect Message (2591)
Patient Problem Burn(s) (1757)
Event Date 06/24/2017
Event Type  Injury  
Event Description
I have a (b)(6) son who wets the bed at night.We had used a bedwetting alarm a year ago and it gave good results, but his bedwetting has returned.I purchased a malem bedwetting alarm for him from the bedwetting store website last week and it was delivered on saturday.Yesterday we the first night we used the malem product.I set it up on my son at 8:45 pm and at 11:30pm, the alarm got very hot.The back battery door of the alarm had melted from the heat and the batteries had leaked onto his night dress.He has small red patches on his chest from the burns.It was caught right on time or this could have been life threatening for him as he is just a little kid.Bedwetting store.
 
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Brand Name
MALEM BEDWETTING ALARM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL
MDR Report Key6669299
MDR Text Key78541640
Report NumberMW5070622
Device Sequence Number1
Product Code KPN
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 06/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2017
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Age6 YR
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