BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 21905278 · Received April 24, 2025

    Report

    Report Number
    9617229-2025-06816
    Event Type
    Injury
    Date Received
    April 24, 2025
    Date of Event
    January 1, 2017
    Report Date
    June 20, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    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 REPORT TO A MEDWATCH SUBMITTED UNDER MANUFACTURE REPORT NUMBER 9617229-2024-0011675. 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/WILL BE REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE REASON(S) FOR REOPERATION IS/ARE: "SAGGING" AND LATER DEFLATION. CLARIFICATION TO B3 PARTIAL DATE OF EVENT: 2017 WAS PROVIDED.

    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 COMPLAINT CODES ARE: - DEFLATION: OBSERVED AN OPENING ASSESSED AS SURGICAL DAMAGE. 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.

    Description of Event or Problem · 0

    PATIENT CALLED TO REPORT LEFT SIDE "SAGGING" AND LATER DEFLATION. PHYSICIAN CONFIRMED EVENT. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    PATIENT CALLED TO REPORT LEFT SIDE "SAGGING" AND LATER DEFLATION. PHYSICIAN CONFIRMED EVENT. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481088 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 2072081

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Required Intervention