BEUDAMED
    FDA Adverse Event Other Summary report: N

    TYSHAK II

    MDR report key: 353455 · Received September 25, 2001

    Report

    Report Number
    1318694-2001-00005
    Event Type
    Other
    Date Received
    September 25, 2001
    Date of Event
    July 20, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DESCRIBE EVENT OR PROBLEM: FAILED TO INFLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43431 TYSHAK II PTA CATHETER LIT NUMED, INC. 105 TT-1175

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Other