BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 115 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 19933911 · Received August 7, 2024

    Report

    Report Number
    9617229-2024-18382
    Event Type
    Injury
    Date Received
    August 7, 2024
    Date of Event
    March 12, 2024
    Report Date
    September 11, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5, D6B, H6.

    Additional Manufacturer Narrative · 0

    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: RUPTURE, CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL LATER REPORTED BAKER "GRADE 1", UN-REPORTING. DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    PATIENT REPORTED RIGHT SIDE RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546449 STYLE 115 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1640506

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention