BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERISCAFFOLD SURGICAL SCAFFOLD (US)

    MDR report key: 2944080 · Received February 1, 2013

    Report

    Report Number
    3008374097-2013-00002
    Event Type
    Injury
    Date Received
    February 1, 2013
    Date of Event
    February 29, 2012
    Report Date
    February 29, 2012
    Manufacturer
    ALLERGAN
    Product Code
    FTL
    PMA / PMN Number
    K080442
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE LABELING ADDRESSES THE REPORTED EVENTS OF CREASE/FOLDING OF IMPLANT AND VISIBILITY/PALPABILITY AS FOLLOWS: "ADVERSE REACTIONS ARE THOSE TYPICALLY ASSOCIATED WITH SURGICALLY IMPLANTABLE MATERIALS, INCLUDING INFECTION POTENTIATION, INFLAMMATION, ADHESION FORMATION, FISTULA FORMATION, AND EXTRUSION".

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT DURING A STAGE II BREAST RECONSTRUCTION PROCEDURE THE PT HAD A "PALPABLE REGION AT THE INTERFACE OF THE SCAFFOLD AND PECTORALIS" ON THE RIGHT SIDE, WHICH WAS FOUND TO BE RELATED TO A "SMALL WELL INTEGRATED PIECE OF SCAFFOLD (APPROXIMATELY 1.5 CM X 0.5 CM) THAT SEEMED TO HAVE FOLDED OVER ON ITSELF". THE PHYSICIAN SURGICALLY REMOVED THE PIECE THAT WAS FOLDED OVER. THE BREAST IMPLANT WAS INTRODUCED AND THE REST OF THE DEVICE REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43748 SERISCAFFOLD SURGICAL SCAFFOLD (US) FTL ALLERGAN NA P2011062801B

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention STYLE 15 SILACONE| STYLE 133MX TISSUE EXPANDER| IMPLANTED:| EXPLANTED:| GEL FILLED BREAST IMPLANT| IMPLANTED: