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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD MALEM MEDICAL; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL LTD MALEM MEDICAL; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Model Number 42-BLUE
Device Problems No Audible Alarm (1019); Overheating of Device (1437)
Patient Problem Discomfort (2330)
Event Type  Injury  
Event Description
This is a brand new alarm unit from malem.The unit does not emit any sound.; it only vibrated when it detected urine.Tried it for 2 nights but vibrations did not wake my son from sleep, and he complained that it was so bulky and uncomfortable.The third night the alarm vibrated again and when i checked on my son, i smelled something burning.It was the smell from the alarm.The alarm was burning from inside and was hot to touch.I promptly removed it from my son bit it was not cooling down.I then had to remove the batteries (with great difficulty).The defective product was returned to manufacturer a week later, the heat was substantial from the alarm.I think if i would have checked on my son a bit later, he could have been easily burnt by the heat of the alarm.Fda safety report id # (b)(4).
 
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Brand Name
MALEM MEDICAL
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD
MDR Report Key8659320
MDR Text Key146944309
Report NumberMW5087064
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 05/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number42-BLUE
Device Catalogue NumberULTIMATE ALARM
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age6 YR
Patient Weight23
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