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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD., UK MALEM; ENURESIS ALARM
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MALEM MEDICAL LTD., UK MALEM; ENURESIS ALARM Back to Search Results
Device Problems Leak/Splash (1354); Overheating of Device (1437)
Patient Problem Caustic/Chemical Burns (2549)
Event Date 08/22/2018
Event Type  Injury  
Event Description
Parents brought in a child who was burnt from using an enuresis alarm.The parents have said that their child put on the enuresis alarm at night as he did for the last 1 week and went to sleep, but that night, the alarm portion malfunctioned and caused the batteries to leak within the alarm.The leak also spread on the outside of the alarm and was not contained within the alarm part as the back side of the enuresis alarm bent inward from excessive heat.The alarm was shown to the attending physician who confirmed the same.The alarm burnt the child in the neck and throat area.Although the burns were very minor, they are still noteworthy due to the nature of the incident and the child's age.Pediatrician attended to and discharged the child.Parents have requested anonymity.
 
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Brand Name
MALEM
Type of Device
ENURESIS ALARM
Manufacturer (Section D)
MALEM MEDICAL LTD., UK
lowdham, nottingham
UK 
MDR Report Key7826233
MDR Text Key118593502
Report NumberMW5079436
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 Health Care Professional
Type of Report Initial
Report Date 08/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/28/2018
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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