BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGARD

    MDR report key: 9454665 · Received December 11, 2019

    Report

    Report Number
    3004513970-2019-00002
    Event Type
    Malfunction
    Date Received
    December 11, 2019
    Date of Event
    June 20, 2019
    Report Date
    December 11, 2019
    Manufacturer
    DUKAL CORPORATION
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LAP SPONGE WITH LOOSE SHREDDING FIBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250229 REGARD SPONGE LAP X-RAY DET GDY DUKAL CORPORATION 236354REG LK22018

    Patients

    Seq Age Sex Outcome Treatment
    1