BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SA2086 NSSA

    MDR report key: 1821552 · Received August 26, 2010

    Report

    Report Number
    1282497-2010-00016
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    July 23, 2010
    Report Date
    July 28, 2010
    Manufacturer
    COVIDIEN
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2010. AN INVESTIGATION IS CURRENTLY ON THE UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2010 THAT A CUSTOMER HAD AN ISSUE WITH A X-RAY SPONGE. THE CUSTOMER STATES THE SPONGES WILL FRAY AND BREAK APART AFTER THE PRODUCT IS SUBMERGED IN BLOOD/FLUID AND SITS FOR A PERIOD OF TIME. THE CUSTOMER STATES THAT NO SPONGES FELL APART IN THE BODY CAVITY AND MEDICAL INTERVENTION WAS NOT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SA2086 NSSA X-RAY SPONGE GDY COVIDIEN SA2086 688330

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK