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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM BED WETTING DEVICE; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL LTD. MALEM BED WETTING DEVICE; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Model Number M043
Device Problems Leak/Splash (1354); Device Emits Odor (1425); Self-Activation or Keying (1557); Unexpected Shutdown (4019)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/23/2019
Event Type  Injury  
Event Description
The bedwetting device which is brand new is abruptly turning on and off.It requires 2 batteries which comes with the device and a sensor which is inserted into the alarm device.However when the sensor is inserted, the device is heating up.Not acting like it is safe to use.It was in my pocket and within 15 mins, it was hot.I felt the heat and removed it.I did not take out the batteries.Then, about 30 mins later, it smelled of burning plastic and something happened to the device which made the batteries leak and spread outside on the countertop where it was sitting.I reached out for the device, but it was too hot to hold.There is no way this can be used for my(b)(6) y/o son specially in his sleep.Too dangerous.Fda safety report id# (b)(4).
 
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Brand Name
MALEM BED WETTING DEVICE
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD.
MDR Report Key8551119
MDR Text Key143373949
Report NumberMW5086177
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 Family Member or Friend
Type of Report Initial
Report Date 04/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberM043
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 Age3 YR
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