BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 15 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 21782662 · Received April 6, 2025

    Report

    Report Number
    9617229-2025-05595
    Event Type
    Injury
    Date Received
    April 6, 2025
    Date of Event
    January 29, 2010
    Report Date
    June 1, 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

    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. PAIN: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. AS PER THE INVESTIGATION PROCEDURE, CREASE, WEAR ABRASION AND NON-PENETRATING NICK WERE COMPLETED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW-UP REPORT TO A MEDWATCH SUBMITTED UNDER MANUFACTURE REPORT NUMBER 9617229-2024-0011441. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. 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 "PAIN". HEALTHCARE PROFESSIONAL CONFIRMED RIGHT SIDE INTRACAPSULAR RUPTURE DIAGNOSED VIA MRI. DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    PATIENT REPORTED "PAIN". HEALTHCARE PROFESSIONAL CONFIRMED RIGHT SIDE INTRACAPSULAR RUPTURE DIAGNOSED VIA MRI. DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1736383 STYLE 15 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1773851

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention