BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INMED

    MDR report key: 54938 · Received July 29, 1996

    Report

    Report Number
    54938
    Event Type
    Injury
    Date Received
    July 29, 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 SHOWS 29 CM LONG SEGMENT OF PLASTIC WIRE WITH MFR'S LABEL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization| R