BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURE CATHETER

    MDR report key: 5923360 · Received September 1, 2016

    Report

    Report Number
    3005471919-2016-00005
    Event Type
    Injury
    Date Received
    September 1, 2016
    Date of Event
    August 5, 2016
    Report Date
    September 1, 2016
    Manufacturer
    CURE MEDICAL LLC
    Product Code
    EZD
    PMA / PMN Number
    K132500
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO DEVICE WAS RETURNED, SO NO EVALUATION COULD BE PERFORMED ON THE ACTUAL DEVICE. LOT NUMBER IS UNKNOWN SO DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A REVIEW OF COMPLAINT HISTORY FOR DEVICE DID NOT REVEAL A KNOWN DEVICE PROBLEM. USER HAS A HISTORY OF URINARY TRACT INFECTION COMMONLY ASSOCIATED WITH ROUTINE CATHETERIZATION. USER ALSO MENTIONED THAT AFTER BEGINNING USE OF BZK TO DISINFECT THAT ROUTINE HAND WASHING WAS DISCONTINUED. USER WAS ADVISED TO RESUME HAND WASHING REGIMEN. MANUFACTURER IS UNABLE TO CONFIRM THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    USER REPORTED EXPERIENCING URINARY TRACT INFECTIONS WHILE USING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573768 CURE CATHETER URINARY CATHETER EZD CURE MEDICAL LLC HM14

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other