BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 22866994 · Received August 21, 2025

    Report

    Report Number
    9617229-2025-14305
    Event Type
    Injury
    Date Received
    August 21, 2025
    Date of Event
    July 25, 2025
    Report Date
    November 28, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    UDI-DI
    10888628000438
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 WAS ANOTHER RECORD FOR UNITS MANUFACTURED ON LOT NUMBER 1220027: (B)(6): A1406 INFLATION PROBLEM. DEVICE RETURNED TO DEVICE ANALYSIS. THE SEARCH CRITERIA OF THESE QUERIES ARE MENTIONED ON QPP07-01- 004-HER1-G02 WORDING GUIDELINES FOR COMPLAINT INVESTIGATION CLOSURE REVISION 6.0. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5, D6(B), H6.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2410588 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 1220027 10888628000438

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention