BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERI SURGICAL SCAFFOLD (US)

    MDR report key: 5476552 · Received March 3, 2016

    Report

    Report Number
    8020862-2016-00017
    Event Type
    Injury
    Date Received
    March 3, 2016
    Report Date
    February 10, 2016
    Manufacturer
    ALLERGAN (MEDFORD)
    Product Code
    OXF
    PMA / PMN Number
    K123128
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON 3/3/2016. (B)(4). THE NUMBER OF SERI® DEVICES INVOLVED IS UNCLEAR FROM THE REPORT. THEREFORE, MFG REPORT NUMBER MFG REPORT NUMBER 8020862-2016-00018 REPRESENTS THE DEVICE IMPLANTED IN THIS PATIENT'S LEFT BREAST. CLARIFICATION: THE CODE FOR PATIENT PROBLEM/MEDICAL PROBLEM WAS SELECTED TO REPORT THE PATIENT'S MENTAL AND NERVOUS PAIN AND SUFFERING. THESE EVENTS REPRESENT PHYSIOLOGICAL COMPLICATIONS, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. ALLERGAN IS UNABLE TO CONFIRM WITH THE HEALTHCARE PROFESSIONAL, THEREFORE ADDITIONAL EVENT, PRODUCT, OR PATIENT DETAILS ARE NOT ATTAINABLE. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF INFLAMMATION 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

    MEDWATCH SENT TO FDA ON 4/8/2016. (B)(4). MFG REPORT NUMBER 8020862-2016-00018 AND 8020862-2016-00017 HAVE BEEN DETERMINED TO BE ASSOCIATED WITH THE SAME DEVICE.

    Description of Event or Problem · 1

    PATIENT'S ATTORNEY REPORTED PATIENT EXPERIENCED CHRONIC INFLAMMATION, PAIN, EMOTIONAL STRESS/TRAUMA, AND MENTAL, PHYSICAL AND NERVOUS PAIN AND SUFFERING. THIS COMPLAINT IS ASSOCIATED WITH A SERI SURGICAL SCAFFOLD DEVICE PLACED IN THE RIGHT BREAST.

    Description of Event or Problem · 1

    PATIENT'S ATTORNEY REPORTED PATIENT EXPERIENCED CHRONIC INFLAMMATION, PAIN, EMOTIONAL STRESS/TRAUMA, AND MENTAL, PHYSICAL AND NERVOUS PAIN AND SUFFERING. THIS COMPLAINT IS ASSOCIATED WITH A SERI SURGICAL SCAFFOLD DEVICE PLACED IN THE RIGHT BREAST. FOLLOW-UP INFORMATION RECEIVED FROM THE PATIENT'S PHYSICIAN INDICATED THAT ONE SERI DEVICE WAS PLACED BILATERALLY IN THE BREASTS DURING REVISION TO BREAST AUGMENTATION. POST-IMPLANTATION, THE PATIENT DEVELOPED NECROTIC TISSUE ON THE LEFT BREAST ONLY. THE CONCOMITANT BREAST IMPLANT BECAME EXPOSED. THE PHYSICIAN REMOVED THE BREAST IMPLANT, NECROTIC TISSUE AND SERI FROM THE LEFT BREAST APPROXIMATELY 3 MONTHS AFTER IMPLANTATION. THE DEVICE REMAINS IMPLANTED ON THE RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132689 SERI SURGICAL SCAFFOLD (US) MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY OXF ALLERGAN (MEDFORD) P12091101

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention