BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 115 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 12421608 · Received September 3, 2021

    Report

    Report Number
    9617229-2021-49673
    Event Type
    Injury
    Date Received
    September 3, 2021
    Date of Event
    June 9, 2021
    Report Date
    October 7, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED ONE EXTENDED OPENING, FOLD CREASES AND BROWN PARTICLES MATERIAL WAS FOUND ON THE SHELL. 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. 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

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE EXCHANGE FROM TEXTURED TO SMOOTH DUE TO PATIENT CONCERN WITH THE PRODUCT. HEALTHCARE PROFESSIONAL REPORTED ADDITIONAL EVENT OF RUPTURE. 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: PATIENTS CONCERN WITH PRODUCT AND RUPTURE.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE EXCHANGE FROM TEXTURED TO SMOOTH DUE TO PATIENT CONCERN WITH THE PRODUCT. HEALTHCARE PROFESSIONAL REPORTED ADDITIONAL EVENT OF RUPTURE. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1320571 STYLE 115 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2277728

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention