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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 ULTIMATE BEDWETTING ALARM
Device Problems Leak/Splash (1354); Overheating of Device (1437); Defective Device (2588)
Patient Problems Bruise/Contusion (1754); Superficial (First Degree) Burn (2685)
Event Date 09/06/2019
Event Type  Injury  
Event Description
Pt is a (b)(6) female with nocturnal enuresis.Parents purchased an enuresis alarm for the pt and was used for one night.Parents set up the alarm and sensor on the pt and placed the alarm on her clothing as described in the user manual.However the alarm developed an internal defect and short which caused the electronics to short circuit and overheat.The result was that the batteries leaked out and the alarm reached an unusually high temperature.Since the alarm was in contact with the pt's body.It scarred her skin and left her with bruises.The battery leaked on pt's skin and made the situation even more worse.Parents said that the alarm was smelling like a burning piece of plastic.The alarm is no longer operational.Fda safety report id# (b)(4).
 
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Brand Name
MALEM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD.
UK 
MDR Report Key9104168
MDR Text Key159788494
Report NumberMW5089949
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 Other Health Care Professional
Type of Report Initial
Report Date 09/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberULTIMATE BEDWETTING ALARM
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
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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