BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 168 SALINE FILLED BREAST IMPLANT

    MDR report key: 21120409 · Received January 9, 2025

    Report

    Report Number
    9617229-2025-00532
    Event Type
    Injury
    Date Received
    January 9, 2025
    Date of Event
    December 16, 2024
    Report Date
    April 18, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    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/WILL BE REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE REASON FOR REOPERATION IS: CAPSULAR CONTRACTURE BAKER GRADE IV. CONTINUED E1: (B)(6).

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B1, B5, D6A.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: A2, D9, H3, H6. LABORATORY ANALYSIS SUMMARY: THE DEVICE RELATED TO THE REPORTED EVENT OF CAPSULAR CONTRACTURE AND USE ERROR WAS RECEIVED ON FEBRUARY 06, 2025, WITH LOT NUMBER 152469. BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: CAPSULAR CONTRACTURE: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE DEVICE. USE ERROR: OBSERVED PER REPORTED IMPLANTED DATE. AS PER THE INVESTIGATION PROCEDURES OBSERVED AN OPENING ALSO OBSERVED TOTAL DELAMINATION IN THE PLUG STRAP DISK SHELL, CREASES AND WEAR ABRASION WERE COMPLETED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT-SIDE CAPSULAR CONTRACTURE BAKER GRADE IV WITH PAIN. ADDITIONALLY, ¿IMPLANT DATE REPORTED DOES NOT MATCH WITH DEVICES' EXPIRATION DATE¿. DEVICE HAS BEEN EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT-SIDE CAPSULAR CONTRACTURE BAKER GRADE IV WITH PAIN. THE EVENT OF DEVICE HANDLING PROBLEM WAS CONFIRMED TO NOT HAVE OCCURRED. THEREFORE, IT WILL BE UNREPORTED. DEVICE HAS BEEN EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT-SIDE CAPSULAR CONTRACTURE BAKER GRADE IV WITH PAIN. ADDITIONALLY, ¿IMPLANT DATE REPORTED DOES NOT MATCH WITH DEVICES' EXPIRATION DATE¿. DEVICE HAS BEEN EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1376446 STYLE 168 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 152469

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention