BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 468 SALINE FILLED BREAST IMPLANT

    MDR report key: 13510252 · Received February 10, 2022

    Report

    Report Number
    9617229-2022-02143
    Event Type
    Injury
    Date Received
    February 10, 2022
    Date of Event
    April 12, 2021
    Report Date
    December 5, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF CAPSULAR CONTRACTURE WAS RECEIVED ON JUNE 04, 2021, WITH CATALOG NUMBER 1850273. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: CREASE FOLD AND OPENING ON ANTERIOR. MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED: STRIATED OPENING ON ANTERIOR. THE FILL TEST INSPECTION WAS PERFORMED, THE RESULT IS NO BLOCKAGE. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: A STRIATED OPENING ASSESSED AS SURGICAL DAMAGE CONSIST IN THE USE OF SOME SURGICAL TOOL.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. 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. THE REASON FOR REOPERATION: CAPSULAR CONTRACTURE BAKER GRADE III.

    Description of Event or Problem · 0

    PATIENT CALLED TO FOLLOW UP REGARDING AN ADVERSE EVENT/WARRANTY CLAIM. AFFECTED SIDE IS LEFT. HEALTHCARE PROFESSIONAL REPORTED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE CLASS 3. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    PATIENT CALLED TO FOLLOW UP REGARDING AN ADVERSE EVENT/WARRANTY CLAIM. AFFECTED SIDE IS LEFT. HEALTHCARE PROFESSIONAL REPORTED BILATERAL CAPSULAR CONTRACTURE CLASS 3. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118905 STYLE 468 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 1850273

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention