BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURE CATHETER WITH INSERTION KIT

    MDR report key: 11289327 · Received February 5, 2021

    Report

    Report Number
    3005471919-2021-00017
    Event Type
    Injury
    Date Received
    February 5, 2021
    Date of Event
    January 7, 2021
    Report Date
    February 12, 2021
    Manufacturer
    CURE MEDICAL LLC
    Product Code
    OHR
    PMA / PMN Number
    K072539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE K2 INSERTION KIT (GLOVES, BZK WIPE, COLLECTION BAG, UNDERPAD, LUBRICATING JELLY) WAS ALSO IN USE BUT THE M14 CATHETER IS THE MOST RELEVANT SUSPECT DEVICE.

    Additional Manufacturer Narrative · 0

    THE M14 CATHETER IS MOST RELEVANT TO THE DEVICE PROBLEM.

    Additional Manufacturer Narrative · 1

    LIMITED INFORMATION ABOUT THE EVENT WAS AVAILABLE. ATTEMPTS TO FOLLOW UP WITH THE PATIENT (USER) AND GAIN ADDITIONAL INFORMATION DID NOT RECEIVE A RESPONSE.

    Description of Event or Problem · 1

    INTERMITTENT CATHETER PATIENT (USER) SAID SHE IS CURRENTLY BEING TREATED FOR A URINARY TRACT INFECTION (UTI) CONCURRENT WITH CATHETER AND INSERTION KIT (GLOVES, BZK WIPE, COLLECTION BAG, LUBRICATING JELLY) USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185445 CURE CATHETER WITH INSERTION KIT CATHETER CARE TRAY OHR CURE MEDICAL LLC M14

    Patients

    Seq Age Sex Outcome Treatment
    1 Other