BEUDAMED
    FDA Adverse Event Other Summary report: N

    SURGIMEND

    MDR report key: 3063090 · Received April 12, 2013

    Report

    Report Number
    3004170064-2013-00057
    Event Type
    Other
    Date Received
    April 12, 2013
    Report Date
    April 12, 2013
    Manufacturer
    TEI BIOSCIENCES INC.
    Product Code
    FTM
    PMA / PMN Number
    083898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT HAD A BILATERAL MASTECTOMY AND UNDERWENT BILATERAL BREAST RECONSTRUCTION. THE DATE OF THE SURGERY IS NOT KNOWN. THE SURGIMEND DEVICE WAS IMPLANTED IN ADDITION TO PERMANENT GEL IMPLANTS. SUBSEQUENTLY, THE LEFT SIDE BECAME INFECTED (DATE UNK) AND SPONTANEOUSLY OPENED A SPOT ABOVE THE INCISION ON THE LATERAL BREAST AND TRIED TO EXTRUDE THE IMPLANT. TWO UNUSUAL ORGANISMS GREW (SPECIES AND GENUS UNK). THE RECONSTRUCTION WILL NEED TO BE REPEATED. IT IS NOT KNOWN WHAT THE CURRENT CONDITION OF THE PT IS. THERE WAS NO PRODUCT CATALOG NUMBER OR PRODUCT LOT NUMBER PROVIDED SO A SPECIFIC DEVICE HISTORY RECORD COULD NOT BE REVIEWED. ALL SURGIMEND DEVICES ARE TERMINALLY STERILIZED USING A VALIDATED STERILIZATION PROCESS. IT IS NOT LIKELY THAT THE DEVICE WAS THE CAUSE OF THE INFECTION THAT LEAD TO THE PT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158101 SURGIMEND SURGICAL MESH FTM TEI BIOSCIENCES INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other