BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETY SPONGE SYSTEM

    MDR report key: 2688087 · Received August 7, 2012

    Report

    Report Number
    3005868511-2012-00004
    Event Type
    Malfunction
    Date Received
    August 7, 2012
    Date of Event
    July 9, 2012
    Report Date
    July 9, 2012
    Manufacturer
    SURGICOUNT MEDICAL INC.
    Product Code
    GDY
    PMA / PMN Number
    K060076
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT CONFIRMED IF THE DMT LABEL SEPARATED FROM THE SPONGE DURING PROCEDURE. MORE INFORMATION IS REQUIRED TO FULLY INVESTIGATE THE ISSUE. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT TO BE SENT.

    Description of Event or Problem · 1

    THE DATA MATRIX TAG (DMT) LABEL WAS MISSING FROM THE SPONGE DURING COUNT-OUT. USER REPORTED THAT THERE WERE NO SIGNS OF THE DMT LABEL ON THE SPONGE OR ON THE STERILE FIELD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1