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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD. BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS

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MALEM MEDICAL LTD. BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Model Number M042
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem Shock (2072)
Event Date 10/01/2019
Event Type  malfunction  
Event Description
The bedwetting alarm was never used.It was purchased online from the mfr's website, so i know i got a genuine one.It came well packed.Before i set it up on my daughter, i decided to test it first with a little water.When i put water on the sensor, the alarm started to beep.I was about to remove the sensor when i got a shock on my hand from the alarm.The sensor was wet and it made the alarm beep, but me getting a shock was unacceptable.I removed batteries and changed them.Then i asked my wife to try it and she poured some water on her finger tips and touched the sensor.She also got a shock.Something is scarily wrong with this device.The sensor will be coming in contact with urine which is liquid and it will give my daughter shocks.This is just too dangerous for us.I have the alarm if you need to check it.Fda safety report id# (b)(4).
 
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Brand Name
BEDWETTING ALARM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD.
MDR Report Key9156432
MDR Text Key161389526
Report NumberMW5090212
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 10/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberM042
Device Catalogue NumberMALEM ULTIMATE PRO BEDWETTING
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age6 YR
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