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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD MALEM; ALARM, CONDITIONED RESPONSE
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MALEM MEDICAL LTD MALEM; ALARM, CONDITIONED RESPONSE Back to Search Results
Model Number M05
Device Problems Mechanical Problem (1384); Overheating of Device (1437); Material Deformation (2976)
Patient Problem Burn, Thermal (2530)
Event Date 11/09/2018
Event Type  Injury  
Event Description
Six year old male child was treated for skin burns resulting from the continued use of an enuresis alarm.Parents used the enuresis alarm as directed however the device has an electrical/mechanical defect causing it to overheat and burn the child's neck while he was asleep.Assisting nurse has appropriately treated the child and recommended parents to discontinue using and enuresis alarm.The particular brand is the malem ultimate alarm which burnt the child.Excess heat has also caused the back housing of the alarm to bend and change shape.The patient is still recovering from the incident and has burn scars on his neck.We expect the scars to fade away within 3-5 months.
 
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Brand Name
MALEM
Type of Device
ALARM, CONDITIONED RESPONSE
Manufacturer (Section D)
MALEM MEDICAL LTD
GB 
MDR Report Key8089736
MDR Text Key128248478
Report NumberMW5081471
Device Sequence Number1
Product Code KPN
Combination Product (y/n)N
Reporter Country CodeCO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 11/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Device Model NumberM05
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/19/2018
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) Hospitalization;
Patient Age6 YR
Patient Weight24
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