BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 115 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 10740947 · Received October 27, 2020

    Report

    Report Number
    9617229-2020-17102
    Event Type
    Injury
    Date Received
    October 27, 2020
    Date of Event
    September 25, 2020
    Report Date
    April 9, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE ANALYSIS: VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED BROWN PARTICLES MATERIAL WAS FOUND ON THE SHELL, FOLD CREASES AND ONE EXTENDED OPENING. A WEIGHT TEST OF THE DEVICE WAS VERIFIED AND THE DEVICE UNDERWEIGHT. A MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFY: ONE SHARP EDGE OPENING IN THE SHELL WITH STRESS MARKS AND WEAR ABRASION. A DIMENSION MEASUREMENT IN THE SHELL WAS PERFORMED WHICH IDENTIFY THE THICKNESS WITHIN SPECIFICATION. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: -A SHARP EDGE OPENING IN THE SHELL WITH STRESS MARKS IN THE SIDE POSTERIOR ASSESSED AS SURGICAL IMPACT OPENING.

    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: RUPTURE.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. HEALTHCARE PROFESSIONAL ALSO REPORTED "ARTHRITIS IN BOTH HANDS"; THIS EVENT IS NOT DEVICE RELATED. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1207033 STYLE 115 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2025997

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention