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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM MULTI-CHOICE ALARM; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL LTD. MALEM MULTI-CHOICE ALARM; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Model Number MO17 - DARK BLUE
Device Problem Overheating of Device (1437)
Patient Problem Pain (1994)
Event Date 05/09/2019
Event Type  Injury  
Event Description
My malem multi-choice bed wetting alarm has a serious defect which makes the alarm inoperable and dangerous to operate.It came with batteries preinstalled.I set it up on my son and he went to bed.He came out of his room 20 mins later and said that the alarm was hurting him.I removed it and to my surprise, the alarm was hot.Thinking it would be defective.I immediately removed the batteries from the alarm and that made the alarm cool down.However when i reinserted the batteries, it started getting hot.I took batteries from my remote control and the same thing happened.Changed 3 other battery sets but this alarm just keeps heating up.It's not warm, it is hot, very hot.One can't hold it in their hand, left alone sleep with it.This is a defective bed wetting alarm and to think a child would use, it is not possible.Fda safety report id# (b)(4).
 
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Brand Name
MALEM MULTI-CHOICE ALARM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD.
MDR Report Key8615909
MDR Text Key145407373
Report NumberMW5086681
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 05/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2019
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberMO17 - DARK BLUE
Device Catalogue NumberMO17 - DARK BLUE
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 Age6 YR
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