BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETY SPONGE SYSTEM

    MDR report key: 2364643 · Received July 22, 2011

    Report

    Report Number
    3005868511-2011-00002
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    May 27, 2011
    Report Date
    June 23, 2011
    Manufacturer
    SURGICOUNT MEDICAL
    Product Code
    GDY
    PMA / PMN Number
    K060076
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE 2006, OVER (B)(4) MILLION (B)(4) (STERILE) LAPAROTOMY SPONGES WITH DATA MATRIX LABELS HAVE BEEN DISTRIBUTED AND IN 2011, (B)(4) HAVE BEEN DISTRIBUTED. SINCE 2008, USERS AND SURGICOUNT MEDICAL HAVE BECOME AWARE OF FOUR INSTANCES OF THIS SPECIFIC DEVICE PROBLEM AND MDRS WERE FILED ON EACH OCCASION. SURGICOUNT WILL PROVIDE A FOLLOWUP REPORT SUMMARIZING THE STATUS OF THE INVESTIGATION NOTED BY (B)(6) 2011. WILL BE COMPLETED IN THE FOLLOWUP REPORT. WE WILL ALSO REPORT PATIENT STATUS INFORMATION IF AVAILABLE.

    Description of Event or Problem · 1

    THIS MALFUNCTION REPORT ORIGINALLY FILED BY THE USER FACILITY UNIVERSITY OF MICHIGAN HEALTH SYSTEM, ANN ARBOR, MI. AS UF REPORT (B)(4). THE DATA MATRIX CODED LABEL USED FOR SPONGE ACCOUNTABILITY WAS OBSERVED TO BE DAMAGED AT THE END OF A SURGICAL PROCEDURE AND COULD NOT BE SCANNED OUT. IT IS NOT KNOWN WHETHER THE DAMAGE OCCURRED PRIOR TO USE OR DURING THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFETY SPONGE SYSTEM NON-ABSORBABLE GAUZE, INTERNAL (GDY) GDY SURGICOUNT MEDICAL SM-1818-PB

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO