BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 23139098 · Received September 24, 2025

    Report

    Report Number
    9617229-2025-16234
    Event Type
    Injury
    Date Received
    September 24, 2025
    Date of Event
    August 29, 2025
    Report Date
    December 10, 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

    CLARIFICATION: D6A- IMPLANT YEAR- 2005 RECEIVED.

    Additional Manufacturer Narrative · 0

    E1. ZIP CODE CONTINUED: (B)(6). 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. REASON FOR REOPERATION: DEFLATION, CREASE/FOLDING OF IMPLANT.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "DEFLATION". HEALTHCARE PROFESSIONAL LATER REPORTED ON RGA "ANY CREASES ASSOCIATED WITH HOLE". DEVICE HAS BEEN EXPLANTED, REPLACED AND DISCARDED. DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "DEFLATION". HEALTHCARE PROFESSIONAL LATER REPORTED ON RGA "ANY CREASES ASSOCIATED WITH HOLE". DEVICE HAS BEEN EXPLANTED, REPLACED AND DISCARDED. DEVICE WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1642219 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 1101939

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention