BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 120 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 14792157 · Received June 23, 2022

    Report

    Report Number
    9617229-2022-10223
    Event Type
    Injury
    Date Received
    June 23, 2022
    Report Date
    June 23, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION CONTAINED IN THIS REPORT WAS PREVIOUSLY SUBMITTED THROUGH PSR ON 22/JAN/2015, 21/JAN/2016, AND 18/APR/2016. INITIAL REPORTER- ADDRESS: (B)(6). (B)(4). 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 · 0

    HEALTHCARE PROFESSIONAL REPORTED "EXTRAVASATION OF SILICONE" AGAINST LEFT SIDE DEVICE. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308020 STYLE 120 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2002180

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention