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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD ULTIMATE BEDWETTING ALARM BY MALEM; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL LTD ULTIMATE BEDWETTING ALARM BY MALEM; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Model Number ULTIMATE MO42
Device Problems Device Dislodged or Dislocated (2923); Temperature Problem (3022)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 07/27/2019
Event Type  Injury  
Event Description
My biggest problem with this product is the length of the cord.The second night my daughter wore this i started to question how safe the cord was.With the unit attached inside her pajama collar and the sensor attached to her underwear and the cord running inside, there was enough cord to wrap around her neck.I assumed that is a possibility which would not happen.I was wrong.When i checked on her 30 minutes later, the cord was actually round her neck she is average height and this is so dangerous.Having a cord could strangle her.Secondly the unit was smelling bad like its burning and when i removed it, it was actually noticeably hot.Not very hot, but hot enough to realize that any more heat and it will cause significant injuries.
 
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Brand Name
ULTIMATE BEDWETTING ALARM BY MALEM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD
MDR Report Key8856359
MDR Text Key153226120
Report NumberMW5088669
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 07/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberULTIMATE MO42
Device Catalogue NumberMO42
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 Age5 YR
Patient Weight23
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