BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 19764935 · Received July 17, 2024

    Report

    Report Number
    9617229-2024-17054
    Event Type
    Injury
    Date Received
    July 17, 2024
    Date of Event
    April 1, 2024
    Report Date
    September 15, 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

    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 UNKNOWN.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: ¿ DEFLATION: OBSERVED ONE OPENING ASSESSED AS SURGICAL DAMAGE AND ONE OPENING ASSESSED AS FOLD FLAW OPENING. ¿ CAPSULAR CONTRACTURE: UNABLE TO OBSERVE SINCE IT IS A MEDICAL EVENT AND IS NOT RELATED TO THE DEVICE. ¿ PARTICLES IN VALVE: NO OBSERVED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED A RIGHT-SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. HEALTHCARE PROFESSIONAL LATER PROVIDED BAKER GRADE II/III AND PARTICLE IN VALVE. HEALTHCARE PROFESSIONAL REPORTED DAMAGED CAUSED BY IMPLANT MARKED "YES"- PUNCHED THE IMPLANT TO REMOVE. THE DEVICE WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED A RIGHT-SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE II/III AND PARTICLE IN VALVE. HEALTHCARE PROFESSIONAL REPORTED DAMAGED CAUSED BY IMPLANT MARKED "YES"- PUNCHED THE IMPLANT TO REMOVE. DEVICE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355058 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 2716897

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention