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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD MALEM ULTIMATE BEDWETTING ENURESIS ALARM; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL LTD MALEM ULTIMATE BEDWETTING ENURESIS ALARM; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Model Number BLUE PRO
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Pain (1994); Rash (2033); Scarring (2061); Skin Inflammation (2443)
Event Date 10/08/2019
Event Type  Injury  
Event Description
My daughter has been using the malem bedwetting alarm for a little under a week and has developed severe skin rash where the alarm is touching skin.The sensor is clipped on underwear and the cable is under her shirt.After a week of use, she has one scar which is exactly where we placed the alarm (her neck).The other red area is a result of the cable on her body.I do feel that the alarm is warm when operated but thought that it is normal.It's on the hotter side.It could also be some contaminant or chemical in the alarm and cable which has caused the redness.Either way, the redness is severe and she is in pain from using this alarm.We have discontinued use.Fda safety report id#: (b)(4).
 
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Brand Name
MALEM ULTIMATE BEDWETTING ENURESIS ALARM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD
MDR Report Key9197034
MDR Text Key162708578
Report NumberMW5090403
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 10/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberBLUE PRO
Device Catalogue NumberBLUE PRO
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age5 YR
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