BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 18730778 · Received February 19, 2024

    Report

    Report Number
    9617229-2024-02676
    Event Type
    Injury
    Date Received
    February 19, 2024
    Date of Event
    November 6, 2023
    Report Date
    May 3, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED: A.4., WEIGHT: 65.40 KG E.1. ZIP CODE: (B)(6). STATE: (B)(6). 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. THE EVENT OF "CAPSULAR CONTRACTURE" IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. 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: CAPSULAR CONTRACTURE, BAKER GRADE III.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: CAPSULAR CONTRACTURE: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. MALPOSITION: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. ADDITIONAL OBSERVATIONS: NO OTHER OBSERVATIONS OBSERVED ON THE DEVICE. NO FURTHER ACTIONS ARE REQUIRED AS THE DEVICE WAS IMPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED EXCHANGE DUE TO A RIGHT DEVICE DEFLATION. HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III AND IMPLANT MALPOSITION. THIS IS FOR THE LEFT SIDE DEVICE. THE DEVICE HAS BEEN EXPLANTED

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED EXCHANGE DUE TO A RIGHT DEVICE DEFLATION. HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III AND IMPLANT MALPOSITION. THIS IS FOR THE LEFT SIDE DEVICE. THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541430 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 2167420

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention