BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURE MEDICAL

    MDR report key: 6139205 · Received December 1, 2016

    Report

    Report Number
    3005471919-2016-00008
    Event Type
    Injury
    Date Received
    December 1, 2016
    Date of Event
    November 1, 2016
    Report Date
    December 1, 2016
    Manufacturer
    CURE MEDICAL LLC
    Product Code
    OHR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: EVENT INFORMATION WAS REPORTED TO MANUFACTURER VIA A DISTRIBUTOR. DISTRIBUTER WOULD NOT PROVIDE USER'S CONTACT INFORMATION NOR PERFORM ADDITIONAL FOLLOW-UP ON MANUFACTURER'S BEHALF SO ADDITIONAL FOLLOW-UP COULD NOT BE INITIATED. MANUFACTURER IS UNABLE TO DIRECTLY CONFIRM DETAILS OF THE EVENT INCLUDING IF A DRY BZK WIPE WAS ACTUALLY OBSERVED BY THE USER OR OTHER POTENTIALLY IMPORTANT DETAILS. NO DEVICE WAS RETURNED, SO NO EVALUATION COULD BE PERFORMED ON THE ACTUAL DEVICE. THEREFORE THE MANUFACTURER IS UNABLE TO CONFIRM THE REPORTED PRODUCT PROBLEM OR IF IT MAY HAVE CAUSED OR CONTRIBUTED TO EVENT.

    Description of Event or Problem · 1

    USER EXPERIENCED UTI WHILE USING CATHETER INSERTION KIT. USER'S MOTHER ASKED IF A DRY BZK WIPE MAY CONTRIBUTE TO EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789255 CURE MEDICAL URINARY CATHETER (INSERTION) TRAY OHR CURE MEDICAL LLC K2 15B03802

    Patients

    Seq Age Sex Outcome Treatment
    1 Other