BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD-PARKER

    MDR report key: 3901454 · Received June 19, 2014

    Report

    Report Number
    1836161-2014-00034
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 22, 2014
    Report Date
    June 19, 2014
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    GES
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(6) ORDERS WITH (B)(4). DOCTOR REPORTED 3 BLADES SPLITTING DURING USE. HIP SURGERY. YES THIS BLADE IS USED FOR HIP PROCEDURE. THE CENTER OF THE BLADE SPLIT. PATIENT WAS NOT AFFECTED. PROCEDURE WAS DELAYED. TWO INCIDENTS WHEN THE BLADE ACTUALLY SPLIT. SO THE SURGEON HAD TO RETRIEVE THE BLADE. ANOTHER INCIDENT SAW THE BLADE HAD SPLIT DURING USE. THE SURGEON STOPS THE PROCEDURE AND REMOVES ALL OF THE BLADE. NO DEVICES USED ALONG WITH THE BLADE. THE BLADE WAS STORED AND HANDLES PER STANDARD OF CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361762 BARD-PARKER STAINLESS STEEL BLADES SIZE 10, STERILE GES ASPEN SURGICAL PRODUCTS, INC. 371210

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention