BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 15 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 14831447 · Received June 27, 2022

    Report

    Report Number
    9617229-2022-10631
    Event Type
    Injury
    Date Received
    June 27, 2022
    Date of Event
    January 1, 2021
    Report Date
    July 25, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE FAX ALL PAPERWORK TO THE SURGERY CENTER AT 250 314 1196, SENDING KIT TO SURGERY CENTER ATTENTION KIM, 200-741 SAHALI TERRACE ROOM, PHONE 250-314-0076, CITY KAMLOOPS, BC EXT.CANADA, FAX-250-314-1196, POSTAL CODE-V2C 6X7 MOBILE,NO EMAIL [email protected]. (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. 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. 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: CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND RUPTURE.

    Description of Event or Problem · 0

    PHYSICIAN REPORTED RIGHT SIDE RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    PHYSICIAN REPORTED RIGHT SIDE RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2019074 STYLE 15 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1500702

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention