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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM ENURESIS ALARM; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL LTD. MALEM ENURESIS ALARM; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Model Number M05S
Device Problems Leak/Splash (1354); Melted (1385); Overheating of Device (1437)
Patient Problem Burn, Thermal (2530)
Event Date 10/15/2018
Event Type  Injury  
Event Description
A (b)(6) child was brought into the urgent care dept for neck burns.The child was using an enuresis alarm at night when it malfunctioned and overheated.The malfunction caused the alarm to get very hot and burn the child at the point of contact on his neck.Parents reported that the alarm has also changed shape (plastic part) from the excess heat that was dissipated by the alarm.Batteries leaked out as a result of the overheating.The child was bruised and treated by the attending nurse and later discharged.There are f/u visits to see how the child is doing.Parents have been told to discontinue using the enuresis alarm and report the incident to the fda.
 
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Brand Name
MALEM ENURESIS ALARM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD.
lowdham, nottingham NG14 7EJ
UK  NG14 7EJ
MDR Report Key7984251
MDR Text Key124501629
Report NumberMW5080685
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 Other Health Care Professional
Type of Report Initial
Report Date 10/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2018
Is this an Adverse Event Report? Yes
Device Operator No Information
Device Model NumberM05S
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) Required Intervention;
Patient Age9 YR
Patient Weight29
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