BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 21731771 · Received March 31, 2025

    Report

    Report Number
    9617229-2025-05162
    Event Type
    Injury
    Date Received
    March 31, 2025
    Date of Event
    February 24, 2025
    Report Date
    May 30, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D9 H3 H6. LABORATORY ANALYSIS SUMMARY THE DEVICE RELATED TO THE REPORTED EVENT DEFLATION WAS RECEIVED ON APRIL 23, 2025. WITH LOT NUMBER 1180123. BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: DEFLATION: OBSERVED AN OPENING ASSESSED AS AN UNIDENTIFIED (TEAR) OPENING. AS PER THE INVESTIGATION PROCEDURE, CREASES WERE COMPLETED AND NONE OF THE OBSERVATIONS WERE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED.

    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.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED DEFLATION. THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED DEFLATION. THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934182 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 1180123

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention