BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 120 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 11787054 · Received May 6, 2021

    Report

    Report Number
    9617229-2021-16480
    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

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF DEVICE APPEARS TO TRIGGER REJECTION, CAPSULAR CONTRACTURE WAS RECEIVED ON JUN 07, 2021 WITH LOT NUMBER 1243042. VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED; YELLOW PARTICLES IN SHELL, DEFORMATION, WEIGHT WITHIN SPECIFICATION. AFTER AUTOCLAVE CYCLE WAS OBSERVED: CLOUDY GEL. OBSERVED ¿SPLIT IN PATCH (SS)¿, IT IS OUT OF SPECIFICATION PER QA199.04 AND IT IS ASSESSED AS WORKMANSHIP. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: - SPLIT IN PATCH ASSESSED AS WORKMANSHIP.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL MEDWATCH BEING SUBMITTED TO CORRECT G3 WHICH WAS INITIALLY SUBMITTED INCORRECTLY.

    Description of Event or Problem · 0

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

    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 DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682872 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