BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERI SURGICAL SCAFFOLD (US)

    MDR report key: 4223537 · Received October 29, 2014

    Report

    Report Number
    3008374097-2014-00109
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    September 23, 2014
    Report Date
    October 1, 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

    FURTHER INFO FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. THE EVENT OF INFECTION IS A PHYSIOLOGICAL COMPLICATION, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF INFECTION AS FOLLOWS: ADVERSE REACTIONS ARE THOSE TYPICALLY ASSOCIATED WITH SURGICALLY IMPLANTABLE MATERIALS, INCLUDING INFECTION, INFLAMMATION, ADHESION FORMATION, FISTULA FORMATION, AND EXTRUSION. THIS EVENT IS BEING REPORTED BECAUSE MED INTERVENTION WAS REQUIRED, ALTHOUGH DEVICE RELATEDNESS HAS NOT BEEN ESTABLISHED.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED IMPLANTATION OF SERI ON (B)(6) 2014 DURING BILATERAL BREAST LIFT SURGERY. POST-IMPLANTATION ON (B)(6) 2014, PT PRESENTED WITH FLUID AND REDNESS IN THE RIGHT BREAST. A DIAGNOSTIC CULTURE RESULTED IN STAPHYLOCOCCUS AUREUS GROWTH. TREATMENT INCLUDED ASPIRATION OF THE FLUID AND ANTIBIOTICS. DEVICE REMAINS IMPLANTED AND IS UNAVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692716 SERI SURGICAL SCAFFOLD (US) OXF ALLERGAN NA P13082701A

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention