BEUDAMED
    FDA Adverse Event Other Summary report: N

    90043170 DERMACEA X-RAY SPG 4X4 16 PLY

    MDR report key: 2831320 · Received November 2, 2012

    Report

    Report Number
    1282497-2012-00026
    Event Type
    Other
    Date Received
    November 2, 2012
    Report Date
    October 9, 2012
    Manufacturer
    WINNER MEDICAL C/O STRATA
    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) 2012. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. PRODUCT MONITORING CONTACTED THE CUSTOMER REQUESTING ADD'L INFO BUT NO FURTHER INFO WAS AVAILABLE. IF ADD'L INFO IS OBTAINED, THE MEDWATCH FORM WILL BE UPDATED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012, THAT A CUSTOMER HAD AN ISSUE WITH A XRAY 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 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 90043170 DERMACEA X-RAY SPG 4X4 16 PLY XRAY DETECTABLE SPONGE GDY WINNER MEDICAL C/O STRATA 441601 12070202

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other