BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARD PARKER RIB-BACK BLADE

    MDR report key: 2987949 · Received February 22, 2013

    Report

    Report Number
    1836161-2013-00076
    Event Type
    Other
    Date Received
    February 22, 2013
    Date of Event
    May 22, 2012
    Report Date
    February 22, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO A RECENT (B)(4) INSPECTION, THIS MDR IS BEING REPORTED LATE AS A RESULT OF A RE-EVALUATION.

    Description of Event or Problem · 1

    BLADES ARE NOT HOLDING WELL. THEY ARE SNAPPING FAIRLY EASILY. THE ARE USING THEM TO CUT A RUBBERIZED MASKANT. THEY REALIZE THIS IS NOT THE INTENDED PURPOSE OF THE BLADE. THEY FOLLOW A TEMPLATE, AND WHEN THEY MAKE A BEND, IT SNAPS. THE BLADES SEEM MORE BRITTLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78440 BARD PARKER RIB-BACK BLADE BLADE, SURGICAL GES ASPEN SURGICAL PRODUCTS, INC. 0002291

    Patients

    Seq Age Sex Outcome Treatment
    1