BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 10991862 · Received December 11, 2020

    Report

    Report Number
    9617229-2020-20585
    Event Type
    Injury
    Date Received
    December 11, 2020
    Date of Event
    May 21, 2020
    Report Date
    December 11, 2020
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ARTICLE CITATION: "RISK FACTORS FOR CAPSULAR CONTRACTURE: A RETROSPECTIVE STUDY IN IMMEDIATE RECONSTRUCTION VERSUS DELAYED RECONSTRUCTION;¿ MAIKO DE KERCKHOVE, MD, PHD, YOSHIKO IWAHIRA, MD, PHD; WOLTERS KLUWER HEALTH INC.; PRS GLOBAL OPEN 2020; 21 MAY 2020; THE AMERICAN SOCIETY OF PLASTIC SURGEONS 2020. THE EVENTS OF SEROMA, INFECTION, ISCHEMIA, WOUND DEHISCENCE, NECROSIS, AND EXPOSURE ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. FURTHER INFORMATION FROM THE REPORTER CANNOT BE REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASONS FOR REOPERATION INCLUDE: SEROMA, INFECTION, ISCHEMIA, WOUND DEHISCENCE, NECROSIS, EXPOSURE, AND/OR UNRELATED CAPSULAR CONTRACTURE, BAKER GRADE III OR IV (DUE TO PREVIOUS TISSUE EXPANDER).

    Description of Event or Problem · 1

    JOURNAL ARTICLE ¿RISK FACTORS FOR CAPSULAR CONTRACTURE: A RETROSPECTIVE STUDY IN IMMEDIATE RECONSTRUCTION VERSUS DELAYED RECONSTRUCTION¿ REPORTED COMPLICATIONS FOLLOWING DELAYED TEXTURED, ¿IMPLANT INSERTION¿ OF ¿HEMATOMA, SEROMA, INFECTION, ISCHEMIC SKIN WOUND, EXPOSURE OCCURRENCE.¿ PATIENT WAS CONSIDERED TO EXPERIENCE HEMATOMA ¿IF HISTORY OF HEMATOMA REMOVAL OR A SUBCUTANEOUS HEMORRHAGE BEYOND THE DISSECTION AREA¿ AND SKIN ISCHEMIA ¿JUDGED TO BE PRESENT IN THE CASE OF NECROSIS OR DEHISCENCE OF THE WOUND MARGIN OR NIPPLE AREOLA REGIONS.¿ BAKER GRADE III OR IV WAS DIAGNOSED FOR ALL PATIENTS WITH CAPSULAR CONTRACTURE FORMATION. IT WAS REPORTED THAT ¿LIKELY THAT THE CAPSULE CONTRACTURE FORMATION IS SIMPLY ASSOCIATED WITH THE EXPANDER OPERATION.¿ EVENTS OCCURRED ON AN UNKNOWN SIDE. THE EVENT OF HEMATOMA WAS DEEMED NOT RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1456699 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CHEMOTHERAPY, HORMONE THERAPY, RADIATION