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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD MALEM; ALARM, CONDITONED RESPONSE ENURESIS
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MALEM MEDICAL LTD MALEM; ALARM, CONDITONED RESPONSE ENURESIS Back to Search Results
Device Problems Electrical /Electronic Property Problem (1198); Overheating of Device (1437); Battery Problem (2885)
Patient Problems Pain (1994); Burn, Thermal (2530)
Event Date 01/22/2019
Event Type  malfunction  
Event Description
We have received a complaint from patient that the enuresis alarm has caused skin burns under normal operation.The patient is a young 8 year old girl who has been diagnosed with secondary enuresis.The pediatrician prescribed an enuresis alarm for the treatment.Parents purchased alarm from (b)(6) website and it was shipped to them.The alarm has injured child by short circuiting in the night when patient was asleep.Parents noticed that alarm was a little warm when they set it up on daughter, but the patient was in pain an hour later from the short circuit.Batteries leaked from excess heat and injured child.Also, the child has been traumatized and refuses to continue any alarm treatment.
 
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Brand Name
MALEM
Type of Device
ALARM, CONDITONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD
MDR Report Key8310527
MDR Text Key135766780
Report NumberMW5083715
Device Sequence Number1
Product Code KPN
Combination Product (y/n)N
Reporter Country CodeMX
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 02/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/30/2019
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age8 YR
Patient Weight28
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