BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 10437436 · Received August 21, 2020

    Report

    Report Number
    9617229-2020-12947
    Event Type
    Injury
    Date Received
    August 21, 2020
    Date of Event
    January 1, 2018
    Report Date
    February 17, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 (B)(6) 2021 THROUGH (B)(6) 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¿ ATTACHED. CONSIDERING THAT THERE IS NOT AN ADVERSE TREND FOR THIS TYPE OF EVENT NO ADDITIONAL ACTIONS ARE DEEMED REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    PATIENT REPORTED LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    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 · 1

    PATIENT REPORTED LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903954 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 2518989

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female Required Intervention