BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 120 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 11788388 · Received May 6, 2021

    Report

    Report Number
    9617229-2021-16509
    Event Type
    Injury
    Date Received
    May 6, 2021
    Date of Event
    March 3, 2021
    Report Date
    May 5, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA. DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF DEVICE APPEARS TO TRIGGER REJECTION AND CAPSULAR CONTRACTURE WAS RECEIVED ON JUNE 07, 2021 WITH LOT NUMBER: 1243042. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: WEIGHT TO THE SPEC, OPENING CURVED ON ANTERIOR, CREASES FOLD, WEAR ABRASION AND BROWN PARTICLES IN THE SHELL. A VISUAL AND MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED: STRIATED OPENING ON ANTERIOR. BASE ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: A STRIATED OPENING ON ANTERIOR ASSESSED AS SURGICAL DAMAGE CONSIST IN THE USE OF SOME SURGICAL TOOL.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED PAIN AND CAPSULAR CONTRACTURE BAKER GRADE III BILATERALLY. THE DEVICES HAVE BEEN EXPLANTED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. THE EVENT OF CAPSULAR CONTRACTURE IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. 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: CAPSULAR CONTRACTURE BAKER GRADE III.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED PAIN AND CAPSULAR CONTRACTURE BAKER GRADE III BILATERALLY. THE DEVICES HAVE BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684510 STYLE 120 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1243042

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention