BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGLE SILICONE CATHETER

    MDR report key: 10784 · Received January 4, 1994

    Report

    Report Number
    MW1000288
    Event Type
    Injury
    Date Received
    January 4, 1994
    Date of Event
    November 26, 1993
    Report Date
    December 13, 1993
    Manufacturer
    AXIOM MEDICAL, INC.
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEVICE RESISTED BEING WITHDRAWN BY PHYSICIAN AND BROKE UPON ATTEMPTED REMOVAL. PT WAS RETURNED TO SURGERY TO REMOVE DISTAL PIECE. RISK TO PT WAS MINIMAL. PT HAS FULLY RECOVERED FROM THE OPEN HEART SURGERY AND RETURNED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGLE SILICONE CATHETER KDQ AXIOM MEDICAL, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention