BEUDAMED
    FDA Adverse Event Other Summary report: N

    VISTEC SPG 4X4 NON ST 10S 16PLY

    MDR report key: 2818480 · Received October 25, 2012

    Report

    Report Number
    1018120-2012-00016
    Event Type
    Other
    Date Received
    October 25, 2012
    Report Date
    September 27, 2012
    Manufacturer
    COVIDIEN
    Product Code
    GDY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. PRODUCT MONITORING CONTACTED THE CUSTOMER REQUESTING ADDITIONAL INFORMATION. ATTEMPTS WERE MADE TO RETRIEVE ADDITIONAL INFORMATION. HOWEVER, THE CUSTOMER REPORTS NO OTHER INFORMATION OF THE EVENT IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A X-RAY DETECTABLE SPONGE. THE CUSTOMER REPORTS THAT DURING A SURGICAL PROCEDURE ON AN OPEN WOUND, THE SPONGE FELL APART IN THE WOUND. THE CUSTOMER FURTHER REPORTS THAT THE FRAYED SPONGE PARTICLES WERE REMOVED IMMEDIATELY WITH NO ILL EFFECT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISTEC SPG 4X4 NON ST 10S 16PLY XRAY DETECTABLE SPONGE GDY COVIDIEN 7148 120001220462X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other