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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL MALEM; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL MALEM; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Model Number M04
Device Problems Fluid/Blood Leak (1250); Temperature Problem (3022); Noise, Audible (3273)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 11/14/2017
Event Type  Injury  
Event Description
Another day of use and the malem alarm that my son uses has heated up to a point where it is dangerous to touch and use.The first night, the alarm was so hot that he could not wear it and refused to put it on tonight.Two nights ago was the second night and as soon as the batteries were inserted, the alarm started to make a strange noise like something was stuck inside and a faint vibration.I put it on my son and within 5 minutes the alarm started getting warm and in 15 minutes was so hot that he removed it and put on the side.It seemed like the product was on fire.Ten minutes after the batteries leaked straight out of the alarm on the bed.My son was not hurt, but this could have been near fatal if not checked on time.
 
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Brand Name
MALEM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL
UK 
MDR Report Key7048993
MDR Text Key92733012
Report NumberMW5073459
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 Attorney
Type of Report Initial
Report Date 11/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberM04
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age4 YR
Patient Weight18
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