BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYSHAK DILATATION CATHETER

    MDR report key: 288013 · Received July 27, 2000

    Report

    Report Number
    1318694-2000-00004
    Event Type
    Malfunction
    Date Received
    July 27, 2000
    Date of Event
    November 2, 1998
    Report Date
    July 27, 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

    THE PTA BALLOON BURST AT 1ATM DURING AN UNSPECIFIED PROCEDURE. THERE WAS NO REPORT OF INJURY TO THE PT. NUMED CONTACTED THE DISTRIBUTOR WHO PROVIDED THE INITIAL REPORT TO NUMED BUT COULD NOT OBTAIN ANY ADD'L INFO ABOUT THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYSHAK DILATATION CATHETER PTA CATHETER LIT NUMED, INC. 102 T-0988

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other