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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM ULTIMATE ALARM; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL LTD. MALEM ULTIMATE ALARM; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Model Number BEDWETTING ALARM
Device Problems Leak/Splash (1354); Moisture Damage (1405)
Patient Problems Pain (1994); Scarring (2061); Eye Burn (2523); Burn, Thermal (2530)
Event Date 10/06/2019
Event Type  malfunction  
Event Description
The malem alarm has two parts, a clip which is attached to underwear and the alarm box.The connection is wired.I connected it to my daughter and as i was setting it up.I saw that the clip portion had exposed wires.This is a battery operated system.I did not think much of it and put her to sleep.She woke up 3 hours later screaming in pain.It appears that her urine shorted out the wires and the batteries too.This caused the batteries to heat up the alarm box and hurt.By the time i reached my daughter, she was in pain and scared from the hot alarm that scared her back and chin.This alarm burnt my daughter.She was treated at home, but was worried because there was battery acid on her, so i took her to the clinic for treatment.I have left the alarm with the clinic.Fda safety report id # (b)(4).
 
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Brand Name
MALEM ULTIMATE ALARM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD.
MDR Report Key9174596
MDR Text Key161947672
Report NumberMW5090316
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 10/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2019
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberBEDWETTING ALARM
Device Catalogue NumberBLUE COLOR
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age5 YR
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