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U.S. Department of Health and Human Services

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

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MALEM MEDICAL LTD. MALEM; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Model Number MO48TEC
Device Problems Overheating of Device (1437); Device Contamination with Chemical or Other Material (2944); Noise, Audible (3273)
Patient Problem No Patient Involvement (2645)
Event Date 03/25/2018
Event Type  Injury  
Event Description
My son is using the malem bedwetting alarm.As soon as i installed batteries, the alarm is making a very strange knocking sound.Something is stuck in it.Also, the alarm is getting warm to touch.I replaced batteries, but same thing is happening.After a half hour, the malem alarm is hot and i can't hold it.This is a product quality problem.Alarm was purchased on (b)(6) from (b)(6) website.
 
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Brand Name
MALEM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD.
MDR Report Key7376785
MDR Text Key103805811
Report NumberMW5076168
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 03/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMO48TEC
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 Age9 YR
Patient Weight31
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