BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETY SPONGE SYSTEM

    MDR report key: 2505153 · Received March 21, 2012

    Report

    Report Number
    3005868511-2012-00001
    Event Type
    Malfunction
    Date Received
    March 21, 2012
    Date of Event
    February 22, 2012
    Report Date
    February 22, 2012
    Manufacturer
    SURGICOUNT MEDICAL
    Product Code
    GDY
    PMA / PMN Number
    K060076
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS IN PROCESS. FOLLOW-UP REPORT TO BE SENT. THIS ISSUE OCCURRED DURING AN EDUCATIONAL SESSION (NON-PATIENT CARE), SO THERE WAS NO PATIENT EXPOSURE.

    Description of Event or Problem · 1

    WHEN THE SPONGE PACKAGING WAS FIRST OPENED, THE DATA MATRIX TAG (DMT) LABEL ADHERED TO THE SPONGE WAS LOOSE AT THE EDGE AND TORN WITH A SMALL PIECE MISSING. THE OTHER SPONGES IN THE PACKAGE HAD NO DEFECTS. THE OUTER AND INNER PACKAGING WAS INTACT AND SHOWED NO EVIDENCE OF DAMAGE OR BREAK. THERE WAS NO PATIENT EXPOSURE. THE PROBLEM WAS DISCOVERED BY SURGICOUNT MEDICAL EDUCATION SPECIALIST DURING AN EDUCATION TRAINING SESSION (NON-PATIENT CARE) AT THE HOSPITAL, (B)(6), ON (B)(4) 2012.

    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-PS 7932

    Patients

    Seq Age Sex Outcome Treatment
    1