BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK SERI SURGICAL SCAFFOLD

    MDR report key: 5775810 · Received July 7, 2016

    Report

    Report Number
    8020862-2016-00036
    Event Type
    Injury
    Date Received
    July 7, 2016
    Date of Event
    April 25, 2016
    Report Date
    June 10, 2016
    Manufacturer
    ALLERGAN (MEDFORD)
    Product Code
    OXF
    PMA / PMN Number
    K123128
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON 07/07/2016. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENTS OF INFECTION AND INADEQUATE TISSUE INGROWTH ARE PHYSIOLOGICAL COMPLICATIONS, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. THIS REPORT AND REPORT NUMBER 8020862-2016-00035 WILL BE SUBMITTED FOR THE SAME PATIENT. THIS REPORT IS FOR THE RIGHT SIDE SERI® DEVICE. REPORT NUMBER 8020862-2016-00035 IS FOR THE LEFT SIDE SERI® DEVICE. THE EXPLANTED DEVICE HAS NOT BEEN RETURNED. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. 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."

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE SERI® DEVICE WITH ¿POSSIBLE INFECTION¿ AND ¿SERI® DID NOT INTEGRATE.¿ THE CONCOMITANTLY PLACED SILICONE GEL BREAST IMPLANT WAS EXPLANTED.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED ADDITIONALLY, "BUT CULTURES WERE NEGATIVE- NO INFECTION FOUND."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429124 UNK SERI SURGICAL SCAFFOLD MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY OXF ALLERGAN (MEDFORD) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention