BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP SPONGES

    MDR report key: 2483553 · Received February 27, 2012

    Report

    Report Number
    2483553
    Event Type
    Malfunction
    Date Received
    February 27, 2012
    Date of Event
    January 13, 2012
    Report Date
    February 24, 2012
    Manufacturer
    SURGICOUNT MEDICAL
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STERILE LAP SPONGE OPENED AND HANDED TO FIELD, SCRUB TECHNICIAN BROKE SEAL AND COUNTED EACH SPONGE DOWN TO THE TABLE. IN BETWEEN EACH SPONGE WAS A HAIR. SPONGES IMMEDIATELY REMOVED FROM FIELD. SCRUB TECHNICIAN CHANGED GLOVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP SPONGES GAUZE/SPONGE GDY SURGICOUNT MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR