BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARD-PARKER SURGICAL BLADE

    MDR report key: 3172807 · Received May 31, 2013

    Report

    Report Number
    1836161-2013-00124
    Event Type
    Other
    Date Received
    May 31, 2013
    Date of Event
    April 1, 2013
    Report Date
    May 31, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    GES
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OPENING KNIFE BLADE FOR PROCEDURE IN OPERATING ROOM AND DISCOVERED A DEAD WINGED INSECT IN THE STERILE PEEL PACKAGE. BLADE DID NOT REACH STERILE FIELD. ORIGINAL INTENDED PROCEDURE: TOTAL HIP PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242232 BARD-PARKER SURGICAL BLADE BLADE, SCALPEL GES ASPEN SURGICAL PRODUCTS, INC. 0024486

    Patients

    Seq Age Sex Outcome Treatment
    1 Other