BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 3940175 · Received March 21, 2014

    Report

    Report Number
    2024601-2014-00149
    Event Type
    Injury
    Date Received
    March 21, 2014
    Date of Event
    January 4, 2014
    Report Date
    February 20, 2014
    Manufacturer
    ALLERGAN
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABELING ADDRESSES REPORTED EVENT OF SEROMA AS FOLLOWS: "POSTOPERATIVE HAEMATOMA/SEROMA MAY INHIBIT WOUND HEALING AND REQUIRE SURGICAL CORRECTION AND/OR EXPLANATION." DEVICE LABELING ADDRESSES REPORTED EVENT OF INFECTION AS FOLLOWS: "INFECTION AROUND A BREAST IMPLANT MAY OCCUR WITHIN DAYS, WEEKS, OR EVEN YEARS, AFTER SURGERY. SIGNS OF ACUTE INFECTION REPORTED IN ASSOCIATION WITH IMPLANTS INCLUDE ERYTHEMA, TENDERNESS, FLUID ACCUMULATION, PAIN, AND FEVER. INFECTION THAT IS UNRESPONSIVE TO TREATMENT MAY REQUIRE IMPLANT REMOVAL."

    Description of Event or Problem · 1

    REPORTED EVENT OF SEROMA WITHIN 5 PATIENTS FROM JOURNAL ARTICLE: "SKIN REDUCING MASTECTOMY AND IMMEDIATE RECONSTRUCTION: THE EFFECT OF RADIOTHERAPY ON COMPLICATIONS AND PATIENT REPORTED OUTCOMES", EUROPEAN JOURNAL OF SURGICAL ONCOLOGY: THE JOURNAL OF THE EUROPEAN SOCIETY OF SURGICAL ONCOLOGY AND THE BRITISH ASSOCIATION OF SURGICAL ONCOLOGY, (2014 JAN 22). ELECTRONIC PUBLICATION DATE: 22 JAN 2014. THIS RECORD ADDRESSES THE RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168450 UNK MAMMARY IMPLANT FWM ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention