BEUDAMED
    FDA Adverse Event Other Summary report: N

    SURGIMEND

    MDR report key: 2920197 · Received January 15, 2013

    Report

    Report Number
    3004170064-2012-00068
    Event Type
    Other
    Date Received
    January 15, 2013
    Date of Event
    November 13, 2012
    Report Date
    December 19, 2012
    Manufacturer
    TEI BIOSCIENCES INC.
    Product Code
    FTM
    PMA / PMN Number
    071807
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TWO (2) DEVICES WERE USED: DEVICE # 2: SURGIMEND, P/N 606-004-102, LOT #1101004 MANUFACTURED ON 01/21/2011 WITH AN EXPIRATION DATE OF 07-2013. HISTOLOGY OF DEVICE # 2 SHOWED A NORMAL DERMAL COLLAGEN STRUCTURE, AND A LOW DENSITY OF CELLS THROUGHOUT THE STRUCTURE. THERE WAS NO EVIDENCE OF A FOREIGN BODY REACTION.

    Description of Event or Problem · 1

    THE PATIENT WAS SCHEDULED FOR BREAST RECONSTRUCTION SURGERY. THE TWO DEVICES WERE IMPLANTED ON (B)(6) 2012; ONE UNDER THE UPPER SKIN FLAP (P/N 606-300-006, LOT # 1204052) AND THE OTHER AS A SLING (P/N 606-004-102, LOT # 1101004) UNDER AN EXPANDER WHICH WAS ALSO IMPLANTED. THE SURGERY WENT WELL AND THE PATIENT WAS RECOVERING AS EXPECTED OVER THE NEXT 2-3 WEEKS. IN (B)(6) SHE STARTED TO FEEL "ILL", HOWEVER, WITH NO SIGNS OF INFECTION. HER WHITE BLOOD CELL COUNT WAS NORMAL AND THERE WAS NO FEVER. ON (B)(6) 2012, IT WAS OBSERVED THAT THE CENTER OF THE UPPER DEVICE (P/N 606-300-006) FELT SOFT. PUS WAS ASPIRATED. DURING SURGERY, THE UPPER DEVICE APPEARED TO BE DISSOLVING AND WAS SUBSEQUENTLY EXPLANTED. PART OF THE SECOND DEVICE (P/N 06-004-102) WAS EXCISED AND EXPLANTED. THE REMAINDER WAS LEFT IN THE PATIENT. THE EXPANDER WAS ALSO EXPLANTED. AT THIS TIME THE PATIENT IS DOING AS EXPECTED. THE DOCTOR SUSPECTS EITHER AN INFECTION, HYPER-SENSITIVITY OR AUTO-IMMUNE REACTION LIKE THE PREVIOUSLY DIAGNOSED ERYTHEMA NODOSUM OR TO THE ANTIBIOTICS ADMINISTERED PRIOR TO OR DURING HER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22783 SURGIMEND SURGICAL MESH FTM TEI BIOSCIENCES INC. 606-300-006 1204052

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R