BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 17437844 · Received August 1, 2023

    Report

    Report Number
    9617229-2023-12302
    Event Type
    Injury
    Date Received
    August 1, 2023
    Date of Event
    July 15, 2022
    Report Date
    May 14, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    10888628003781
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. 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 UNKNOWN, ANXIETY-PRODUCT/PROCEDURE.

    Additional Manufacturer Narrative · 0

    LAB ANALYSIS: THE DEVICE IS RELATED TO THE REPORTED EVENT CAPSULAR CONTRACTURE AND ANXIETY ¿ PRODUCT/PROCEDURE OF IMPLANT RECEIVED ON (B)(6) 2024, WITH LOT NUMBER 2982222. 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. ANXIETY ¿ PRODUCT/PROCEDURE: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE DEVICE. 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. REASON FOR REOPERATION: CAPSULAR CONTRACTURE GRADE III.

    Description of Event or Problem · 0

    PATIENT REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND REPLACEMENT FROM TEXTURED TO SMOOTH DUE TO THE PATIENT CONCERN OF THE IMPLANT. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    PATIENT REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN AND REPLACEMENT FROM TEXTURED TO SMOOTH DUE TO THE PATIENT CONCERN OF THE IMPLANT. LATER, HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, GRADE II. HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    IT HAS BEEN DETERMINED THAT THE EVENT ASSOCIATE WITH THIS COMPLAINT DID NOT OCCUR. THIS RECORD IS NO LONGER REPORTABLE TO FDA AND WILL BE UN-REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2338862 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2982222 10888628003781

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention