BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 468 SALINE FILLED BREAST IMPLANT

    MDR report key: 22572256 · Received July 22, 2025

    Report

    Report Number
    9617229-2025-12320
    Event Type
    Injury
    Date Received
    July 22, 2025
    Date of Event
    May 13, 2025
    Report Date
    July 22, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    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-CONFORMANCES NOTED. DHR TREND SUMMARY: THE REVIEW OF HISTORICAL COMPLAINTS ON THE COMPLAINT MANAGEMENT HANDLING SYSTEM IDENTIFIED THAT THERE WERE OTHER RECORDS FOR UNITS MANUFACTURED ON LOT NUMBER 1355044: - 1308950: NO COMPLAINT AGAINST THE DEVICE. DEVICE RETURNED TO DEVICE ANALYSIS. - 2647229: CAPSULAR CONTRACTURE, ANXIETY - PRODUCT/PROCEDURE, A050401 - FLUID/BLOOD LEAK. DEVICE NOT RETURNED TO DEVICE ANALYSIS. - 581572: A1401 - DEFLATION PROBLEM. DEVICE RETURNED TO DEVICE ANALYSIS. - 594305: SIZE EXCHANGE. DEVICE RETURNED TO DEVICE ANALYSIS. - (B)(4): E020201 ANXIETY, A050401 FLUID/BLOOD LEAK. DEVICE RETURNED TO DEVICE ANALYSIS. EVEN THOUGH THERE WERE 2 ADDITIONAL COMPLAINTS OF A050401 FLUID/BLOOD LEAK FOR THIS LOT NUMBER, ONLY 1 DEVICE WAS RETURNED, AND AFTER INSPECTION NO WORKMANSHIPS WERE DETECTED. THE SEARCH CRITERIA OF THESE QUERIES ARE MENTIONED ON QPP07-01-004-HER1-G02 (V6.0) THE REVIEW OF ALL POTENTIAL TREND EVALUATIONS FOR BREAST IMPLANTS CLOSED DURING THE PAST 12 MONTHS INDICATES THAT NO CONFIRMED COMPLAINT TRENDS HAVE BEEN OBSERVED FOR THE EVENT A050401 FLUID/BLOOD LEAK. 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: DEVICE DEFLATION.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE FROM TEXTURED TO SMOOTH DEVICES DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT". HEALTHCARE PROFESSIONAL REPORTED LATER BY OPERATIVE PROCEDURE "RUPTURED". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2751715 STYLE 468 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 1355044

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention