BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICOUNT MEDICAL LAP SPONGES

    MDR report key: 8378218 · Received February 27, 2019

    Report

    Report Number
    MW5084493
    Event Type
    Injury
    Date Received
    February 27, 2019
    Date of Event
    February 7, 2019
    Report Date
    February 7, 2019
    Manufacturer
    SURGICOUNT MEDICAL INC/STRYKER INSTRUMENTS
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    HAIR FOUND IN STERILE PACKAGING WHEN SETTING UP FOR SURGICAL PROCEDURE IN THE OPERATING ROOM. SURGICAL CASE DELAYED, BREAKDOWN OF TABLE AND RESET REQUIRED ONCE HAIR FOUND CAUSED EVIDENCE OF STERILE PROCESS BEING BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166065 SURGICOUNT MEDICAL LAP SPONGES LAP SPONGES, GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE GDY SURGICOUNT MEDICAL INC/STRYKER INSTRUMENTS 9820

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention