BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 115 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 22084886 · Received May 26, 2025

    Report

    Report Number
    9617229-2025-08635
    Event Type
    Injury
    Date Received
    May 26, 2025
    Date of Event
    April 1, 2017
    Report Date
    May 26, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    10888628002388
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW-UP REPORT TO A MEDWATCH SUBMITTED UNDER MANUFACTURE REPORT NUMBER 9617229-2024-0011619. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. REASON FOR REOPERATION: RUPTURE. IN RESPONSE TO FDA REPORT NUMBER: MW5088619. DEVICE EVALUATION: BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: RUPTURE: OBSERVED BROKEN DEVICE ASSESSED AS FOLD FLAW OPENING. ¿ ANXIETY-PRODUCT/PROCEDURE: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. A WORKMANSHIP WAS OBSERVED NOT RELATED TO THE COMPLAINT FOR A SPLIT IN PATCH OBSERVED EVENT. A FURTHER INVESTIGATION IS REQUESTED TO ANALYZE THE SPLIT IN PATCH OBSERVED. AS PER THE INVESTIGATION PROCEDURE, CREASES, NON-PENETRATING NICKS AND WEAR ABRASION WERE 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 VIA REGULATORY AGENCY LEFT SIDE IMPLANT EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT. LATER, HEALTHCARE PROFESSIONAL REPORTED RUPTURE CONFIRMED WITH MRI. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990650 STYLE 115 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2759958 10888628002388

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Required Intervention