BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 15 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 11104962 · Received January 2, 2021

    Report

    Report Number
    9617229-2020-21706
    Event Type
    Injury
    Date Received
    January 2, 2021
    Date of Event
    December 3, 2020
    Report Date
    February 23, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: A VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED CREASE FOLDS AND ONE EXTENDED OPENING. A WEIGHT TEST OF THE DEVICE VERIFIED THE DEVICE TO BE UNDERWEIGHT. A MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED ONE SHARP EDGED OPENING IN THE SHELL WITH STRESS MARKS AND WEAR/ABRASION. A DIMENSION MEASUREMENT IN THE SHELL WAS PERFORMED WHICH IDENTIFIED THE THICKNESS WITHIN SPECIFICATION. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: A SHARP EDGED OPENING IN THE SHELL WITH STRESS MARKS IN THE SIDE RADIUS, ASSESSED AS A SURGICAL IMPACT OPENING. 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.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED CAPSULAR CONTRACTURE, BAKER GRADE UNSPECIFIED. 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: RUPTURE.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158 STYLE 15 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1170803

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention