BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD PARKER

    MDR report key: 4860198 · Received June 20, 2015

    Report

    Report Number
    1836161-2015-00042
    Event Type
    Injury
    Date Received
    June 20, 2015
    Date of Event
    May 21, 2015
    Report Date
    June 16, 2015
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    GES
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING THE SURGERY, THE BLADE WAS BROKEN INTO THE SURGICAL WOUND SITE INTO THE PATIENT. THE SURGEON REMOVED SOME PARTS FROM THE BLADE INTO THE PATIENT. THE PATIENT HAS BEEN ADVISED AFTER SURGERY REGARDING THIS PROBLEM. AN INTERNAL REPORT HAS BEEN PRODUCED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401768 BARD PARKER SAFETYLOCK CARBON RIB-BACK BLADES SI GES ASPEN SURGICAL PRODUCTS, INC. 371151 0058574

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention