BEUDAMED
    FDA Adverse Event Other Summary report: N

    TYSHAK DILATATION CATHETER

    MDR report key: 291447 · Received August 16, 2000

    Report

    Report Number
    1318694-2000-00008
    Event Type
    Other
    Date Received
    August 16, 2000
    Date of Event
    December 1, 1998
    Report Date
    August 16, 2000
    Manufacturer
    NUMED, INC.
    Product Code
    LIT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING NORMAL HANDLING OF THE BALLOON CATHETER THE PLASTIC PART NEAR THE Y COMPONENT BROKE. THE BALLOON BURST ACCORDING TO THE DR LONGITUDINALLY AFTER THE FIRST INFLATION. NOTHING HAPPENED TO THE PT - TO THE CO'S KNOWLEDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYSHAK DILATATION CATHETER PTA CATHETER LIT NUMED, INC. 102 T-0463

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN