BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOUTHMEDIC SCALPEL

    MDR report key: 18245854 · Received November 30, 2023

    Report

    Report Number
    MW5148620
    Event Type
    Malfunction
    Date Received
    November 30, 2023
    Date of Event
    November 9, 2023
    Report Date
    November 28, 2023
    Manufacturer
    SOUTHMEDIC, INC.
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ENTIRE BOX OF SCALPELS DISCOVERED TO CONTAIN DEBRIS INSIDE OF PACKAGE LOT W84086, LOT W84344. REFERENCE REPORT MW5148619.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840887 SOUTHMEDIC SCALPEL BLADE, SCALPEL GES SOUTHMEDIC, INC. W84344

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown