BEUDAMED
    FDA Adverse Event Other Summary report: N

    TYSHAK II

    MDR report key: 353461 · Received September 25, 2001

    Report

    Report Number
    1318694-2001-00003
    Event Type
    Other
    Date Received
    September 25, 2001
    Report Date
    September 25, 2001
    Manufacturer
    NUMED, INC.
    Product Code
    LIT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BALLOON BURST CIRCUMFERENTIALLY AND THE FRONT PART TORE OFF. CATHETER HAD TO BE CUT INTO PIECES FOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43432 TYSHAK II PTA CATHETER LIT NUMED, INC. 105 TT-1097

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other