BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 20 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 12129161 · Received July 7, 2021

    Report

    Report Number
    9617229-2021-46749
    Event Type
    Injury
    Date Received
    July 7, 2021
    Date of Event
    April 27, 2021
    Report Date
    August 25, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    HEALTHCARE PROVIDER CALLED TO REPORT A RIGHT SIDE RUPTURE DISCOVERED DURING SURGERY. THE 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 PROVIDER CALLED TO REPORT A RIGHT SIDE RUPTURE DISCOVERED DURING SURGERY. THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026470 STYLE 20 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2276918

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention