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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL MALEM ; ENURESIS ALARM
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MALEM MEDICAL MALEM ; ENURESIS ALARM Back to Search Results
Device Problems Leak/Splash (1354); Overheating of Device (1437)
Patient Problems Bruise/Contusion (1754); Injury (2348)
Event Date 12/17/2018
Event Type  malfunction  
Event Description
We rented out malem bedwetting alarm to patient who has reported having an adverse effect with alarm.The patient's parents have reported that the young girl has been injured while she was sleeping in bed by the alarm.We have encountered problems with this brand of alarm in the past but we thought that it was an isolated incident and did not report it.Now, we have had a similar incident.In both situations, the alarm has malfunctioned and injured the child.The alarm gets overheated under normal operation causing the batteries to leak out and spill on the child's clothing.Both children were bruised by the battery leak and the hot alarm.There are no burn marks in either case because the child woke up on time and removed the alarm.It is important to note that the issue is a mechanical or electrical design issue with the product which could be potentially dangerous to a sleeping child.
 
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Brand Name
MALEM
Type of Device
ENURESIS ALARM
Manufacturer (Section D)
MALEM MEDICAL
UK 
MDR Report Key8202998
MDR Text Key131897638
Report NumberMW5082665
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 Nurse
Type of Report Initial
Report Date 12/25/2018
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received12/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
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 Age6 YR
Patient Weight20
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