BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERI SURGICAL SCAFFOLD (US)

    MDR report key: 5933317 · Received September 7, 2016

    Report

    Report Number
    8020862-2016-00042
    Event Type
    Injury
    Date Received
    September 7, 2016
    Date of Event
    April 15, 2016
    Report Date
    August 10, 2016
    Manufacturer
    ALLERGAN (MEDFORD)
    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

    THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED. THEREFORE, NO ANALYSIS OR TESTING WILL BE DONE. THE EVENTS OF INFECTION, SEROMA, AND DRAINAGE ARE PHYSIOLOGICAL COMPLICATIONS, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. 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."

    Description of Event or Problem · 1

    ON (B)(6) 2015 THE PATIENT UNDERWENT A PRIMARY RECONSTRUCTION SURGERY IN WHICH SERI® WAS PLACED IN THE INFRAMAMMARY FOLD TO PECTORALIS MAJOR POSITION TO SUPPORT CONCOMITANTLY PLACED 410 COHESIVE SILICONE GEL BREAST IMPLANTS. SERI® WAS DIPPED IN BACITRACIN PRIOR TO IMPLANT AND THE SURGICAL SITE WAS IRRIGATED WITH SAME. ON (B)(6) 2016, THE PATIENT WAS PRESCRIBED DOXYCYCLINE. ON (B)(6) 2016, PHYSICIAN SAW THE PATIENT AND PERFORMED A "DRAINAGE" OF "BUILT UP FLUID." "REDNESS" WAS NOTED. ON (B)(6) 2016 THE PATIENT WAS DIAGNOSED WITH AN INFECTION. ON (B)(6) 2016 THE PATIENT WAS PRESCRIBED AUGMENTIN. ON THE EVENING OF (B)(6) 2016 THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM DUE TO INFECTION AND PAIN, AND ON (B)(6) 2016, THE BREAST IMPLANTS AND SERI® SCAFFOLD WERE REMOVED IN THE ADMITTING HOSPITAL. THE BREAST IMPLANTS AND SERI® WERE ALL DISCARDED. IT IS UNKNOWN WHETHER ANY PORTION OF THE DEVICE REMAINS IMPLANTED. THE PATIENT HAS SINCE FULLY RECOVERED. THIS MEDWATCH REPRESENTS THE RIGHT SIDE. SEE MFR # 8020862-2016-00041 FOR THE LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585904 SERI SURGICAL SCAFFOLD (US) MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY OXF ALLERGAN (MEDFORD) P14121201A

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R ALLERGAN STYLE 410 SILICONE BREAST IMPLANT