BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD-PARKER

    MDR report key: 10260731 · Received July 10, 2020

    Report

    Report Number
    3014527682-2020-00008
    Event Type
    Malfunction
    Date Received
    July 10, 2020
    Date of Event
    June 15, 2020
    Report Date
    July 10, 2020
    Manufacturer
    ASPEN SURGICAL
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    EVENT DISCOVERED DURING PROCEDURE AND INVOLVED PATIENT CONTACT. 10 BLADES IN AT LEAST 3 MAIN OR PACKS ARE DULL. THE DULL BLADES WERE CONTAINED WITHIN ROI CPS, LLC CUSTOM PROCEDURE PACK 880011, LOT 78068.

    Description of Event or Problem · 1

    EVENT DISCOVERED DURING PROCEDURE AND INVOLVED PATIENT CONTACT. 10 BLADES IN AT LEAST 3 MAIN OR PACKS ARE DULL. THE DULL BLADES WERE CONTAINED WITHIN ROI CPS, LLC CUSTOM PROCEDURE PACK 880011, LOT 78068.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725703 BARD-PARKER BLADE SURG RIB BCK CARB 10 GES ASPEN SURGICAL 371110 0209336

    Patients

    Seq Age Sex Outcome Treatment
    1