BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARD PARKER SAFETY BLADES

    MDR report key: 2979982 · Received February 22, 2013

    Report

    Report Number
    1836161-2013-00062
    Event Type
    Other
    Date Received
    February 22, 2013
    Date of Event
    September 23, 2011
    Report Date
    February 22, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    GES
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO A RECENT FDA INSPECTION THIS MDR IS BEING REPORTED LATE AS A RESULT OF A RE-EVALUATION. EVALUATION: ARDEN TEST PERFORMED, FAILED ARDEN TEST.

    Description of Event or Problem · 1

    BLADE NOT SHARP. NO CLEAN CUT. SURGEONS EXPERIENCE INTERMITTENT DRAG DURING INCISION. JAGGED CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77891 BARD PARKER SAFETY BLADES BLADE GES ASPEN SURGICAL PRODUCTS, INC. 1095771

    Patients

    Seq Age Sex Outcome Treatment
    1 Other