BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 20455290 · Received October 15, 2024

    Report

    Report Number
    9617229-2024-22662
    Event Type
    Injury
    Date Received
    October 15, 2024
    Date of Event
    September 17, 2024
    Report Date
    January 13, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCE'S 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: DEFLATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B.5., A.4.

    Additional Manufacturer Narrative · 0

    LABORATORY ANALYSIS SUMMARY THE DEVICE RELATED TO THE REPORTED EVENT OF DEFLATION/CAPSULAR CONTRACTURE WAS RECEIVED ON DEC 09, 2024, WITH LOT NUMBER 2191633. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS ARE: ¿ DEFLATION: OBSERVED OPENING ASSESSED AS FOLD FLAW OPENING. ¿ CAPSULAR CONTRACTURE: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. AS PER THE INVESTIGATION PROCEDURE CREASE WEAR ABRASION 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

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE II". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE II". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED. CAPSULECTOMY PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324694 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 2191633

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention