BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARD PARKER CARBON RIB-BACK BLADE

    MDR report key: 2987946 · Received February 22, 2013

    Report

    Report Number
    1836161-2013-00097
    Event Type
    Other
    Date Received
    February 22, 2013
    Date of Event
    January 28, 2013
    Report Date
    February 22, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    GES
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    THE BLADE IS RIPPING THE TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77972 BARD PARKER CARBON RIB-BACK BLADE BLADE, SURGICAL GES ASPEN SURGICAL PRODUCTS, INC. 0015904

    Patients

    Seq Age Sex Outcome Treatment
    1 Other