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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD MALEM ULTIMATE BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL LTD MALEM ULTIMATE BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Device Problems Overheating of Device (1437); Defective Component (2292)
Patient Problem No Patient Involvement (2645)
Event Date 02/06/2019
Event Type  malfunction  
Event Description
I am a pharmacist and purchased a bedwetting alarm for my son.The alarm was purchased new and it is supposed to detect urine and respond by waking up my son.However this alarm i have received is abnormal.It came with batteries and a urine detection sensor.When i inserted the batteries and changed the modes, things are fine, however when i plug the sensor into the alarm bottom, the alarm starts semi-vibrating.It acts like there is something stuck inside.Within 25 minutes the alarm was hot.The plastic is very hot and the only way to let it cool is to either remove batteries or remove the sensor which defeats the purpose of the product.It can not be used safely with my (b)(6) year old son as the heat can hurt him.I have changed several sets of batteries, but the problem is the same.It is a manufacturing issue and safety issue as well.
 
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Brand Name
MALEM ULTIMATE BEDWETTING ALARM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD
MDR Report Key8337084
MDR Text Key136604501
Report NumberMW5084023
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 02/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age5 YR
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