BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD PARKER

    MDR report key: 3012651 · Received February 22, 2013

    Report

    Report Number
    1836161-2013-00091
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    November 26, 2012
    Report Date
    February 22, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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.

    Description of Event or Problem · 1

    THE #11 BLADE BROKE AS IT WAS REMOVED FROM THE KNIFE HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78466 BARD PARKER #11 SURGICAL BLADE GES ASPEN SURGICAL PRODUCTS, INC. 0014884

    Patients

    Seq Age Sex Outcome Treatment
    1