BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIB CATHETER

    MDR report key: 570843 · Received September 9, 2004

    Report

    Report Number
    1318694-2004-00002
    Event Type
    Malfunction
    Date Received
    September 9, 2004
    Date of Event
    August 6, 2004
    Report Date
    September 9, 2004
    Manufacturer
    NUMED, INC.
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BALLOON DID NOT INFLATE PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIB CATHETER PTA CATHETER LIT NUMED, INC. 420 BIB-1422

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN