BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYSHAK DILATATION CATHETER

    MDR report key: 288024 · Received July 27, 2000

    Report

    Report Number
    1318694-2000-00003
    Event Type
    Malfunction
    Date Received
    July 27, 2000
    Date of Event
    July 21, 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 AN UNSPECIFIED PRESSURE DURING AN UNSPECIFIED PROCEDURE. NO INJURY TO THE PT WAS REPORTED. NUMED CONTACTED THE DISTRIBUTOR WHICH INITIALLY REPORTED THE MALFUNCTION, BUT THE CO COULD NOT OBTAIN ANY ADD'L INFO ABOUT IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYSHAK DILATATION CATHETER PTA CATHETER LIT NUMED, INC. 102 T-1081

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other