BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS FOLLOWER - FILIFORM CATHETER

    MDR report key: 32975 · Received April 2, 1996

    Report

    Report Number
    32975
    Event Type
    Injury
    Date Received
    April 2, 1996
    Date of Event
    March 19, 1996
    Report Date
    April 1, 1996
    Manufacturer
    INMED CORP.
    Product Code
    FBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN ATTEMPTED TO DILATE URETHRA. FILIFORM AND FOLLOWERS USED TO BYPASS AND DILATE URETHRAL STRICTURE. FILIFORM BROKEN AND RETAINED IN THE URETHRA. PATHOLOGY REPORT - 29 CM LONG SEGMENT OF PLASTIC WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS FOLLOWER - FILIFORM CATHETER FILIFORM CATHETER FBW INMED CORP. UNKNOWN 931119

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization| R