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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL LTD. MALEM; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Model Number ULTIMATE BED WETTING ALARM
Device Problems Thermal Decomposition of Device (1071); Overheating of Device (1437); Electrical Shorting (2926)
Patient Problem Burn, Thermal (2530)
Event Date 03/19/2019
Event Type  Injury  
Event Description
Malem ultimate bed wetting alarm was used correctly by pt, but the alarm developed a defect and injured pt.The back side of the alarm and the battery compartment have deformed from excess heat generated by the batteries shorting out while child was sleeping.The alarm was too hot to operate and burnt pt's neck while sleep.The burns were not significant, but were noteworthy of being reported as it could have been worse if pt had not removed alarm on time.Pt has small scars, typical of minor burns and blisters on the area which was in contact with pt.They should heal in 2 - 5 days.
 
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Brand Name
MALEM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD.
UK 
MDR Report Key8473879
MDR Text Key140778032
Report NumberMW5085501
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 03/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberULTIMATE BED WETTING ALARM
Device Catalogue NumberMODEL M04
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/26/2019
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) Required Intervention;
Patient Age7 YR
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