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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL COMPANY MALEM ENURESIS ALARM - PINK; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL COMPANY MALEM ENURESIS ALARM - PINK; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Device Problems Leak/Splash (1354); Overheating of Device (1437)
Patient Problems Erythema (1840); Pain (1994); Swelling (2091); Injury (2348)
Event Date 11/23/2017
Event Type  Injury  
Event Description
I was traveling with my daughter over the long weekend and placed the enuresis alarm in the bag.It was brand new and never used.It has arrived only 2 days prior.At night, when we were going to bed, i put it on my daughter who is only(b)(6).I placed the alarm on the t-shirt top and the sensor on her underwear as per the instructions and put her to bed.Within just 30 minutes, my daughter came crying with her t-shirt all stained.The alarm burnt the batteries and the batteries leaked onto her clothes.The alarm was very hot and it left a big red patch on her chest area.I removed the alarm and immediately gave her a cool bath.The next morning, the patch turned into blisters and was paining badly.She was in pain all night long.The alarm has an issue which caused it to burn up like this and injure my daughter.
 
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Brand Name
MALEM ENURESIS ALARM - PINK
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL COMPANY
MDR Report Key7112034
MDR Text Key94813767
Report NumberMW5073922
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 Other
Type of Report Initial
Report Date 12/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/12/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age4 YR
Patient Weight20
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