BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 15 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 21973753 · Received May 6, 2025

    Report

    Report Number
    9617229-2025-07394
    Event Type
    Injury
    Date Received
    May 6, 2025
    Report Date
    June 26, 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 TO EMDR 9617229-2024-0011534. 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: "MULTIPLE INTER-CAPSULAR RUPTURES".

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D9, H3, H6. DEVICE EVALUATION: BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS ARE: RUPTURE: OBSERVED, OPENING ASSESSED AS FOLD FLAW OPENING AND MISSING ASSESSED AS INCONCLUSIVE. OTHER MEDICAL: UNABLE TO OBSERVE SINCE IT IS A MEDICAL EVENT AND IS NOT RELATED TO THE DEVICE. AS PER THE INVESTIGATION PROCEDURE, NON-PENETRATING NICK WAS COMPLETED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    PATIENT REPORTED OUTCOME OF PREGNANCY, MISCARRIAGE (NOT RELATED TO THE DEVICE). HEALTHCARE PROVIDER REPORTED A LEFT SIDE RUPTURE. PATIENT REPORTED "MULTIPLE INTER-CAPSULAR RUPTURES." THE DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    PATIENT REPORTED OUTCOME OF PREGNANCY, MISCARRIAGE (NOT RELATED TO THE DEVICE). HEALTHCARE PROVIDER REPORTED A LEFT SIDE RUPTURE. PATIENT REPORTED "MULTIPLE INTER-CAPSULAR RUPTURES." THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443877 STYLE 15 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1508344

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention