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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL MALEM ENURESIS ALARM; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL MALEM ENURESIS ALARM; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Model Number M04SC
Device Problem Overheating of Device (1437)
Patient Problem Burn, Thermal (2530)
Event Date 10/16/2018
Event Type  Injury  
Event Description
We were informed of an adverse incident reported to our clinic by parents of a (b)(6) girl.The clinic has prescribed an enuresis alarm which the parents purchased new and used for 1 night before it malfunctioned.The girl has suffered burns on her neck and chest area where the enuresis alarm came in contact with her skin.The cause of the malfunction has been attributed to the malfunctioning medical device.The child did not do anything wrong.The parents brought in the enuresis alarm and it was clear that the heat was excessive and has deformed the device.The child has been visiting the clinic regularly for burn treatment.
 
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Brand Name
MALEM ENURESIS ALARM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL
UK 
MDR Report Key8008833
MDR Text Key125283903
Report NumberMW5080811
Device Sequence Number1
Product Code KPN
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/22/2018
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? Yes
Device Operator No Information
Device Model NumberM04SC
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/25/2018
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 Age7 YR
Patient Weight22
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