BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK SERI SURGICAL SCAFFOLD

    MDR report key: 3940626 · Received June 25, 2014

    Report

    Report Number
    3008374097-2014-00039
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    September 15, 2013
    Report Date
    April 26, 2014
    Manufacturer
    ALLERGAN
    Product Code
    OXF
    PMA / PMN Number
    K123128
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE REPORT OF INFECTION, THE DEVICE IS NOT AVAILABLE FOR RETURN. THEREFORE, ALLERGAN WILL NOT RECEIVE IT AND NO ANALYSIS OR TESTING WILL BE DONE. THE EVENTS OF INFECTION, EXPOSURE, AND NON ADHERENCE ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NO ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF INFECTION AND EXTRUSION AS FOLLOWS: "ADVERSE REACTIONS ARE THOSE TYPICALLY ASSOCIATED WITH SURGICALLY IMPLANTABLE MATERIALS, INCLUDING INFECTION, INFLAMMATION, ADHESION FORMATION, FISTULA FORMATION, AND EXTRUSION." THESE EVENTS ARE BEING REPORTED BECAUSE MEDICAL INTERVENTION WAS REQUIRED, ALTHOUGH DEVICE-RELATEDNESS HAS NOT BEEN ESTABLISHED. FURTHER INFORMATION FROM THE REPORTER REGARDING THE EVENT AND PRODUCT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED IMPLANTATION OD SERI IN THE BREAST ON (B)(6) 2013, DURING A "SALVAGE [LATISSIMUS DORSI]" PROCEDURE. PATIENT PRESENTED ON (B)(4) 2013 WITH "EXPOSED [SERI] AND "SOME INFECTION." TISSUE INTEGRATION WAS REPORTED AS "VERY LITTLE," AND ON (B)(6) 2014, "90+ PERCENT OF THE SERI DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369859 UNK SERI SURGICAL SCAFFOLD OXF ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention