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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD MALEM ULTIMATE BED WETTING ALARM; ALARM CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL LTD MALEM ULTIMATE BED WETTING ALARM; ALARM CONDITIONED RESPONSE ENURESIS Back to Search Results
Catalog Number M04
Device Problems Mechanical Problem (1384); Overheating of Device (1437); Defective Device (2588)
Patient Problems Pain (1994); Swelling (2091); Superficial (First Degree) Burn (2685)
Event Date 02/24/2019
Event Type  Injury  
Event Description
We treated a young boy on (b)(6) who has suffered first degree burn in sleep.The boy was using an enuresis alarm for treatment of primary nocturnal enuresis.The alarm has had an electrical and mechanical failure which caused it to overheat and burn the epidermis.This resulted in pain and reddening of the epidermis.The parents did not realize and check at least 45 minutes into the incident and mistreated the child with cold water.The patient had swelling and blisters.The hospital is treating the boy with another routine follow-up.The alarm is in our possession and we have advised the parents to discontinue using any device at this time.The defect is in the alarm because operation is straight forward and simple.
 
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Brand Name
MALEM ULTIMATE BED WETTING ALARM
Type of Device
ALARM CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD
MDR Report Key8392307
MDR Text Key137994946
Report NumberMW5084643
Device Sequence Number1
Product Code KPN
Combination Product (y/n)N
Reporter Country CodeMX
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 02/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberM04
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) Life Threatening; Other; Required Intervention;
Patient Age4 YR
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