BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK SCAFFOLD

    MDR report key: 3221462 · Received July 9, 2013

    Report

    Report Number
    3008374097-2013-00023
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 8, 2013
    Report Date
    June 10, 2013
    Manufacturer
    ALLERGAN
    Product Code
    FTL
    PMA / PMN Number
    K080442
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. ALLERGAN HAS NOT REC'D THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. LOT NUMBER OF DEVICE AND FURTHER EVENT INFO HAS BEEN REQUESTED. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF CELLULITIS AND REDNESS 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

    ALLERGAN REP REPORTED A RECONSTRUCTION PT WITH ALLERGAN TISSUE EXPANDER AND SERI DEVICE EXPERIENCING "CELLULITIS" AND "RED RASH". A LEFT SIDE REOPERATION WAS NEEDED TO REMOVE THE TISSUE EXPANDER AND SERI DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312004 UNK SCAFFOLD FTL ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention IMPLANTED:| ALLERGAN TISSUE EXPANDER