BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERI SURGICAL SCAFFOLD (US)

    MDR report key: 4203703 · Received October 23, 2014

    Report

    Report Number
    3008374097-2014-00110
    Event Type
    Injury
    Date Received
    October 23, 2014
    Date of Event
    September 18, 2014
    Report Date
    October 2, 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

    (B)(4). THE EVENTS OF INADEQUATE TISSUE INGROWTH AND ERYTHEMA ARE PHYSIOLOGICAL COMPLICATIONS, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. THESE EVENTS ARE 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 AND CONCOMITANT TISSUE EXPANDER ON (B)(6) 2014. AT THE TIME OF TISSUE EXPANDER REMOVAL AND PERMANENT DEVICE REPLACEMENT ON (B)(6) 2014 INADEQUATE TISSUE INGROWTH WAS NOTED. PT PRESENTED ON (B)(6) 2014 WITH ERYTHEMA. TREATMENT INCLUDED ANTIBIOTICS AND REMOVAL OF THE SERI AND BREAST IMPLANT ON (B)(6) 2014. DEVICE WAS COMPLETELY EXPLANTED AND IS AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677055 SERI SURGICAL SCAFFOLD (US) OXF ALLERGAN NA P12073001

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention PT WAS ORIGINALLY IMPLANTED CONCOMITANTLY,| SILICONE GEL BREAST IMPLANT.| REMOVED AND REPLACED WITH A PERMANENT,| WITH A TISSUE EXPANDER DEVICE WHICH WAS,