BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLIFORM WITH SPIRAL TIP

    MDR report key: 34911 · Received July 25, 1996

    Report

    Report Number
    2429473-1996-00005
    Event Type
    Injury
    Date Received
    July 25, 1996
    Date of Event
    July 12, 1996
    Report Date
    July 12, 1996
    Manufacturer
    RUSCH, INC.
    Product Code
    FBW
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TIP BROKE OFF IN PT. PRODUCT PREVIOUSLY USED AND HAD BEEN RESTERILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLIFORM WITH SPIRAL TIP URETHERAL FILIFORM FBW RUSCH, INC. NA 940509

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention