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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 1 TONE ALARM
Device Problems Device Emits Odor (1425); Overheating of Device (1437)
Patient Problem Burning Sensation (2146)
Event Date 01/09/2020
Event Type  Injury  
Event Description
Malem bedwetting alarm purchased with high hopes, but is either defective or faulty, but certainly very dangerous to use.Alarm was placed as per instructions on son while he was asleep and he complained of excess heat and burning smell 10 mins after he went to bed.I checked on it and he was right.The alarm was hot and there was bad smell coming from the alarm.I promptly removed the alarm from him/ his shirt and placed the alarm on the side.After 30 mins, the alarm was no longer hot.The batteries inside the alarm leaked and spilled on the outside of the alarm.The alarm stopped working.This could have seriously injured my son who is only 4 y/o.Fda safety report id# 492345.See scanned pages.
 
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Brand Name
BEDWETTING ALARM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD.
MDR Report Key9591236
MDR Text Key175227859
Report NumberMW5092216
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 01/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number1 TONE ALARM
Device Catalogue NumberULTIMATE PRO
Device Lot NumberBLUE COLOR
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 Age4 YR
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