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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM ULTIMATE BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL LTD. MALEM ULTIMATE BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Device Problems Overheating of Device (1437); Deformation Due to Compressive Stress (2889)
Patient Problem Burn, Thermal (2530)
Event Date 12/27/2018
Event Type  Injury  
Event Description
Doctor had prescribed a nocturnal enuresis alarm to patient.Child is age (b)(6) and wets 4-5 times a week.Parents purchased enuresis alarm from bedwettingstore.Com, an online website which sells nocturnal enuresis alarms.Site is the distributor of malem alarms which is what parents purchased.After one use, the alarm has injured the child.While asleep, alarm malfunctioned and overheated.Since the alarm was placed close to the child's neck, the child has suffered burns on neck area.Parents were informed by child about stinging at night and they removed the alarm to determine cause of burns.Alarm was shown to the pediatrician and returned back to the family.The alarm overheating was not normal and likely caused by the alarm itself and not a fault of operation.Heat has deformed plastic housing of the alarm.
 
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Brand Name
MALEM ULTIMATE BEDWETTING ALARM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD.
MDR Report Key8212597
MDR Text Key132232039
Report NumberMW5082765
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 12/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age7 YR
Patient Weight21
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