BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NO DEVICE

    MDR report key: 5476895 · Received March 3, 2016

    Report

    Report Number
    8020862-2016-00018
    Event Type
    Injury
    Date Received
    March 3, 2016
    Report Date
    February 10, 2016
    Manufacturer
    ALLERGAN (MEDFORD)
    Product Code
    OXF
    PMA / PMN Number
    -
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MED WATCH SENT TO FDA ON 4/8/2016.

    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 8020862-2016-00017 REPRESENTS THE DEVICE IMPLANTED IN THIS PATIENT'S RIGHT BREAST. 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."

    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 LEFT BREAST. ADDITIONAL INFORMATION FROM THE PATIENT'S PHYSICIAN DETERMINED THIS REPORT TO BE A DUPLICATE OF MFG REPORT NUMBER 8020862-2016-00017 REGARDING THE SAME PATIENT AND DEVICE. ONE DEVICE WAS CUT, AND PLACED BILATERALLY IN THE PATIENT'S LEFT AND RIGHT BREAST. ANY ADDITIONAL INFORMATION WILL BE REPORTED ON MFG REPORT NUMBER 8020862-2016-00017.

    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 LEFT BREAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134677 NO DEVICE MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY OXF ALLERGAN (MEDFORD) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention