BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORGES BOUGIE FILIFORM/FOLLOWER

    MDR report key: 278096 · Received April 21, 2000

    Report

    Report Number
    9610711-2000-00001
    Event Type
    Malfunction
    Date Received
    April 21, 2000
    Date of Event
    March 15, 2000
    Report Date
    April 21, 2000
    Manufacturer
    PORGES S.A.
    Product Code
    FBW
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    FILIFORM IS ALLEGED TO HAVE "BROKE" WHERE THE FILIFORM AND FOLLOWER SCREW TOGETHER. THE COMPLAINANT CLAIMS THAT THE PRODUCT HAD NOT BEEN USED (REPROCESSED) MORE THAN 10 TIMES. CYSTOSCOPY WAS CLAIMED TO HAVE BEEN PERFORMED TO REMOVE THE BROKEN PART FROM THE BLADDER WITH NO INJURY OR IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORGES BOUGIE FILIFORM/FOLLOWER URETHRAL DILATATION CATHETER FBW PORGES S.A. AG5R22 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other