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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM ULTIMATE SELECTABLE ENURESIS ALARM; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL LTD. MALEM ULTIMATE SELECTABLE ENURESIS ALARM; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Overheating of Device (1437); Electrical Shorting (2926)
Patient Problem Burn, Thermal (2530)
Event Date 12/06/2018
Event Type  Injury  
Event Description
About two weeks ago, parents had reported that their child was burnt by the nocturnal enuresis alarm.Our clinic routinely recommends alarms to parents and they purchase what they like.In this particular case, parents ordered a malem enuresis alarm.The new device has malfunctioned and when the child was asleep, the alarm "short" out from the inside and overheated.This caused the batteries to explode inside the device and leak on the child¿s clothing.In addition, there was excess heat generated by the device which burnt the child¿s neck.Although the burns were minor and attributed more to stinging, they are important to report.The burns have caused small blisters on the child¿s neck and currently she is undergoing treatment for burns.
 
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Brand Name
MALEM ULTIMATE SELECTABLE ENURESIS ALARM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD.
lowdham, nottingham
UK 
MDR Report Key8186524
MDR Text Key131325381
Report NumberMW5082376
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 12/18/2018
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 Lay User/Patient
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/19/2018
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; Other; Required Intervention;
Patient Age7 YR
Patient Weight35
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