MALEM ALARMS FOR BEDWETTING ULTIMATE 8 TONE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-03 for MALEM ALARMS FOR BEDWETTING ULTIMATE 8 TONE manufactured by Malem Medical Ltd..

Event Text Entries

[182222798] Malem alarm is unreliable. Goes off when not wet and disturbs sleep. When it goes off, the alarm is getting hot. Need to remove the batteries to let it cool down. Dangerous and unreliable. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093492
MDR Report Key9785697
Date Received2020-03-03
Date of Report2020-02-28
Date of Event2020-02-25
Date Added to Maude2020-03-04
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMALEM ALARMS FOR BEDWETTING
Generic NameALARM, CONDITIONED RESPONSE ENURESIS
Product CodeKPN
Date Received2020-03-03
Model NumberULTIMATE 8 TONE
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerMALEM MEDICAL LTD.


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-03

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