BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETY SPONGE SYSTEM

    MDR report key: 2348536 · Received August 19, 2011

    Report

    Report Number
    3005868511-2011-00003
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 21, 2011
    Manufacturer
    SURGICOUNT MEDICAL
    Product Code
    LWH
    PMA / PMN Number
    K060076
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE HAVE INQUIRED AS TO PT STATUS AND, IF AVAILABLE, WILL REPORT THIS AND THE RESULTS OF OUR INVESTIGATION IN A F/U REPORT BY (B)(4) 2011.

    Description of Event or Problem · 1

    THIS IS A MALFUNCTION REPORT ORIGINALLY FILED BY THE USER FACILITY (B)(4) AS UF REPORT (B)(4). A SURGICOUNT MEDICAL LAPAROTOMY SPONGE COULD NOT BE SCANNED OUT AT THE END OF SURGICAL PROCEDURE AND IT WAS OBSERVED THAT PART OF THE DATA MATRIX LABEL ON THE SPONGE WAS MISSING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR