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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM; ENURESIS ALARM
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MALEM MEDICAL LTD. MALEM; ENURESIS ALARM Back to Search Results
Model Number M04SB
Device Problem Temperature Problem (3022)
Patient Problem Burn, Thermal (2530)
Event Date 07/19/2018
Event Type  malfunction  
Event Description
A parent came into our clinic for routine child checkup and treatment of nocturnal enuresis.The parents refused to use another nocturnal enuresis alarm because of a prior experience with another brand.They continue to use ddavp tablets (desmopressin acetate).The parents said that last month ((b)(6) 2018), their daughter was asleep with a malem enuresis alarm when in the middle of the night, the alarm burnt their daughter on the part that touched the child's neck.The young child was in pain and suffered from minor burns in her sleep.She was rushed to the hosp for treatment.About two months later, when the dr met with the child, there were small red burn marks on the child's next from the event.Parents have the enuresis alarm or may have returned it.They mentioned that the alarm was in new condition.
 
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Brand Name
MALEM
Type of Device
ENURESIS ALARM
Manufacturer (Section D)
MALEM MEDICAL LTD.
UK 
MDR Report Key7876353
MDR Text Key120402108
Report NumberMW5079797
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 Nurse
Type of Report Initial
Report Date 09/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2018
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberM04SB
Device Catalogue NumberROYAL BLUE
Was Device Available for Evaluation? No
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 Age4 YR
Patient Weight16
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