BEUDAMED
    FDA Adverse Event Other Summary report: N

    SURGIMEND 3.0

    MDR report key: 2170171 · Received June 24, 2011

    Report

    Report Number
    3004170064-2011-00002
    Event Type
    Other
    Date Received
    June 24, 2011
    Date of Event
    May 27, 2011
    Report Date
    June 24, 2011
    Manufacturer
    TEI BIOSCIENCES INC.
    Product Code
    FTM
    PMA / PMN Number
    K083898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS A (B)(6) FEMALE, (B)(6). FOLLOWING A TOTAL HYSTERECTOMY, BILATERAL SALPINGECTOMY AND DEBRIDEMENT OF A LARGE AREA OF HER ABDOMINAL WALL FASCIA AND RECTUS MUSCLE, THE PRODUCT, SURGIMEND, WAS IMPLANTED ON (B)(6) 2011. ON (B)(6) 2011, THE PT HAD WOUND ERYTHEMA AND NON-SEROUS DRAINAGE. FURTHER SURGERY INVOLVED DEBRIDEMENT OF THE ABDOMINAL WALL AND PLACEMENT OF A WOUND VAC. ADD'L DEBRIDEMENT AND CHANGE OF THE VAC DRESSING OCCURRED ON (B)(6) 2011 AND (B)(6) 2011. SHE CONTINUED TO SPIKE A FEVER WITH ELEVATED WHITE BLOOD CELL COUNT. FROM (B)(6) 2011, SHE UNDERWENT ADD'L SURGICAL DEBRIDEMENT AND VAC CHANGES. ALTHOUGH THE WHITE BLOOD CELL COUNT DECREASED, THE FEVER CONTINUED. EVENTUALLY THE PRODUCT DISINTEGRATED. THE REMAINING PRODUCT WAS EXPLANTED ON (B)(6) 2011 AND REPLACED WITH ANOTHER MESH IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGIMEND 3.0 SURGICAL MESH FTM TEI BIOSCIENCES INC. 606-300-016 0906041

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention