BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 21451651 · Received February 24, 2025

    Report

    Report Number
    9617229-2025-03170
    Event Type
    Injury
    Date Received
    February 24, 2025
    Date of Event
    January 31, 2025
    Report Date
    May 19, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D9 H3 H6. LABORATORY ANALYSIS SUMMARY THE DEVICE RELATED TO THE REPORTED EVENTS DEFLATION WAS RECEIVED ON APRIL 03, 2025 WITH LOT NUMBER 3230563. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINT CODES ARE: DEFLATION: OBSERVED AN OPENING ASSESSED AS FOLD FLAW OPENING. AS PER THE INVESTIGATION PROCEDURE, CREASES AND WEAR ABRASION WERE OBSERVED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 0

    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. THE REASON FOR REOPERATION: DEFLATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: A4, B5, D6B, H6.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. HOLE IN RADIUS (EDGE) OBSERVED DURING SURGERY. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE REMAIN IMPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL LATER REPORTED "HOLE IN RADIUS (EDGE)." DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521304 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 3230563

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention