BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 115 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 22031382 · Received May 15, 2025

    Report

    Report Number
    9617229-2025-08043
    Event Type
    Injury
    Date Received
    May 15, 2025
    Report Date
    August 5, 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 FROM EMDR 9617229-2025-0000066. 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.

    Additional Manufacturer Narrative · 0

    IT HAS BEEN IDENTIFIED THAT THIS RECORD, MRN 9617229-2025-08043, IS A DUPLICATE OF MRN 9617229-2025-07766. PLEASE SEE MRN 9617229-2025-07766 FOR REPORTABLE EVENTS.

    Description of Event or Problem · 0

    PATIENT REPORTED "ITCHING ON THE BREASTS, RED RASH AND IMPLANT EXCHANGE". LATER HEALTHCARE PROFESSIONAL REPORTED RUPTURE CONFIRMED BY MRI. THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    IT HAS BEEN IDENTIFIED THAT THIS RECORD, MRN 9617229-2025-08043, IS A DUPLICATE OF MRN 9617229-2025-07766. PLEASE SEE MRN 9617229-2025-07766 FOR REPORTABLE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73417 STYLE 115 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2251960

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention