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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM BED-WETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL LTD. MALEM BED-WETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Model Number M031
Device Problems Break (1069); Leak/Splash (1354); Overheating of Device (1437); Defective Device (2588)
Patient Problem Skin Irritation (2076)
Event Date 01/09/2019
Event Type  Injury  
Event Description
Reporting an adverse incident with defective children¿s bed -wetting alarm which has injured my daughter.The new bed -wetting alarm was purchased and delivered in excellent condition, but the device is defective.Upon insertion of the urine sensor, the alarm is getting hot.It appeared that the heat generated was the result of normal operation, however this is not correct.The alarm continues to get hot over time and eventually gets to a point where it is unusable and even poses a risk to the user.My daughter was wearing the bed -wetting alarm as one would expect it to be worn, and within 20 minutes, she was screaming in her sleep.On checking, the alarm had gotten hot and injured her in the neck.The point of contact where the alarm and skin touch, has red lines.I removed the alarm and it took another 10 minutes for it to completely stop operating.The heat from the bed-wetting alarm made the batteries explode inside the case and leak out.
 
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Brand Name
MALEM BED-WETTING ALARM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD.
MDR Report Key8248610
MDR Text Key133519363
Report NumberMW5083098
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 Patient
Type of Report Initial
Report Date 01/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberM031
Device Catalogue NumberRED SINGLE TONE
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age9 YR
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