BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 15871165 · Received November 28, 2022

    Report

    Report Number
    9617229-2022-20607
    Event Type
    Injury
    Date Received
    November 28, 2022
    Report Date
    November 28, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. DHR TREND SUMMARY: REVIEW OF ALL COMPLAINTS OF A050401 - FLUID LEAK FOR THE PERIOD OF NOV 2020 THROUGH OCT 2022 RELATED WITH DATE OPENED AND FOUND NO ADVERSE TREND IN THE EVENT RATE WITH RESPECT TO THE REPORTED EVENT. SEE I CHART OF A050401 FLUID LEAK FOR SALINE BREAST IMPLANTS AND ADDITIONAL ANALYSIS¿ ATTACHED. CONSIDERING THAT THERE IS NOT AN ADVERSE TREND FOR THIS TYPE OF EVENT NO ADDITIONAL ACTIONS ARE DEEMED REQUIRED AT THIS TIME. 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

    PATIENT REPORTED RIGHT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1743090 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 2314946

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention