BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 20 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 21954314 · Received May 2, 2025

    Report

    Report Number
    9617229-2025-07216
    Event Type
    Injury
    Date Received
    May 2, 2025
    Date of Event
    February 11, 2025
    Report Date
    May 2, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW-UP REPORT TO A MEDWATCH SUBMITTED UNDER MANUFACTURE REPORT NUMBER 9617229-2025-0000083. 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

    PATIENT REPORTED HAVING BEEN DIAGNOSED WITH A CONNECTIVE TISSUE DISEASE OR DISORDER SINCE THE LAST TIME THEY COMPLETED THEIR QUESTIONNAIRE. FOLLOW UP FINDINGS: PER UBC, THE EVENT OF CONNECTIVE TISSUE DISEASE OR DISORDER WAS MARKED IN ERROR BY THE PATIENT. EVENT RULED OUT. HEALTHCARE PROVIDER REPORTED LEFT SIDE RUPTURE. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072457 STYLE 20 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1492753

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention