BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 20417165 · Received October 10, 2024

    Report

    Report Number
    9617229-2024-22361
    Event Type
    Injury
    Date Received
    October 10, 2024
    Date of Event
    February 1, 2024
    Report Date
    December 18, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B.5., D.6B., H.6., H.11.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: ¿ DEFLATION AND USE ERROR: OBSERVED AN OPENING ASSESSED AS SURGICAL DAMAGE PER RGA. ¿ DELAMINATION: NOT OBSERVED ¿ PARTICLES IN VALVE: NOT OBSERVED. AS PER THE INVESTIGATION PROCEDURES CREASES WERE COMPLETED AND NONE OF THE OBSERVATIONS ARE 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 INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. 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

    PATIENT REPORTED LEFT SIDE DEFLATION. HEALTHCARE PROFESSIONAL LATER CONFIRMED DEFLATION. HEALTHCARE PROFESSIONAL REPORTED VIA RGA "PARTICLES IN VALVE, VALVE DELAMINATED FROM SHELL AND IMPLANT GOT CUT." DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    PATIENT REPORTED LEFT SIDE DEFLATION. HEALTHCARE PROFESSIONAL LATER CONFIRMED DEFLATION. HEALTHCARE PROFESSIONAL REPORTED VIA RGA "PARTICLES IN VALVE, VALVE DELAMINATED FROM SHELL AND IMPLANT GOT CUT." DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    PATIENT REPORTED LEFT SIDE DEFLATION. HEALTHCARE PROFESSIONAL LATER CONFIRMED DEFLATION. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2279733 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 3430302

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Required Intervention