BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDICHOICE DISPOSABLE SCALPEL

    MDR report key: 2892841 · Received December 26, 2012

    Report

    Report Number
    MW5028396
    Event Type
    Injury
    Date Received
    December 26, 2012
    Date of Event
    December 21, 2012
    Report Date
    December 26, 2012
    Manufacturer
    OWENS & MINOR
    Product Code
    GES
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING C-SECTION, THE SCALPEL BROKE AT THE PLASTIC KNOB. THE KNOB FELL INTO THE PT'S ABDOMEN. THE KNOB WAS REMOVED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDICHOICE DISPOSABLE SCALPEL SCALPEL GES OWENS & MINOR

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other