BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACRICATH DCP 3MM PROCEDURE KIT

    MDR report key: 1398643 · Received May 15, 2009

    Report

    Report Number
    1398643
    Event Type
    Malfunction
    Date Received
    May 15, 2009
    Date of Event
    March 26, 2009
    Report Date
    May 15, 2009
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    HNW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BALLOON LEAKED AROUND SEAL AND WOULD NOT HOLD PRESSURE ENOUGH TO MAINTAIN INFLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LACRICATH DCP 3MM PROCEDURE KIT CATHETER, LACRIMAL DUCT HNW QUEST MEDICAL, INC. NA 33472

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR