BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 468 SALINE FILLED BREAST IMPLANT

    MDR report key: 10304960 · Received July 21, 2020

    Report

    Report Number
    9617229-2020-11488
    Event Type
    Injury
    Date Received
    July 21, 2020
    Date of Event
    June 15, 2020
    Report Date
    August 20, 2020
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PHOTO ANALYSIS: VISUAL ANALYSIS OF THE IDENTIFIED PHOTOS: YELLOW BIOLOGICAL TISSUE, OPENING ON RADIUS, DEVICE PATCH WITH LOT NUMBER 2013129, AND LABELED AS RIGHT SIDE. DEVICE ANALYSIS PERFORMED THROUGH PHOTOGRAPHS, DUE TO THE IMPOSSIBILITY TO PERFORM MICROSCOPIC ANALYSIS IT IS NOT POSSIBLE TO DETERMINE THE MOST LIKELY FAILURE MODE.

    Description of Event or Problem · 0

    DEVICE HAS BEEN EXPLANTED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: DEFLATION AND CONCERN OVER TEXTURED IMPLANT.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "DEFLATION AND AN EXCHANGE OF TEXTURED BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT". DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765000 STYLE 468 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 2013129

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention