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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD. ULTIMATE BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL LTD. ULTIMATE BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Model Number ROYAL BLUE
Device Problems Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184); Unstable (1667); Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/01/2019
Event Type  Injury  
Event Description
My step-son¿s bedwetting alarm has become unstable and erratic.It is getting hot at times for no reason.It was working fine for the first two days, then it has suddenly starting getting very hot when he is sleeping.A few nights ago, he came up to me and complained that he had to remove the alarm because it was stinging him.I insisted he wear it and that¿s when i noticed that it's hot.If i could not even hold it in my hands, i would not expect a (b)(6) year old kid to sleep with it.We discontinued using the alarm and tried it again the next day.Unfortunately same results.The alarm is unusable as is.Just keeps becoming hot under normal operation.Practically unsafe for my step son.
 
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Brand Name
ULTIMATE BEDWETTING ALARM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD.
MDR Report Key8311965
MDR Text Key136014351
Report NumberMW5083785
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 02/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberROYAL BLUE
Device Catalogue NumberM04-SB
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 Age6 YR
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