BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 16887804 · Received May 8, 2023

    Report

    Report Number
    9617229-2023-08485
    Event Type
    Injury
    Date Received
    May 8, 2023
    Date of Event
    April 15, 2023
    Report Date
    August 14, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    05060191601597
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: TO THE REPORTED EVENT OF RUPTURE AND CYST-NDR WAS RECEIVED ON (B)(6) 2023 WITH LOT NUMBER 3042301. BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: ¿ RUPTURE: OBSERVED, MISSING SHELL ASSESSED AS INCONCLUSIVE. ¿ CYST-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. ADDITIONAL OBSERVATIONS: ¿ CREASES ARE OBSERVED.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: TO THE REPORTED EVENT OF RUPTURE AND CYST-NDR WAS RECEIVED ON JULY 27, 2023 WITH LOT NUMBER 3042301. BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: ¿ RUPTURE: OBSERVED, MISSING SHELL ASSESSED AS INCONCLUSIVE. ¿ CYST-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. ADDITIONAL OBSERVATIONS: ¿ CREASES ARE OBSERVED.

    Additional Manufacturer Narrative · 0

    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. 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: RUPTURE.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION:VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: RUPTURE: OBSERVED AN OPENING THE DEVICE BUT CANNOT PERFORM AN ASSESSMENT OF THE OPENING AS NO MICROSCOPIC ANALYSIS CAN BE PERFORMED. CYST-NDR: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. IT IS NOT POSSIBLE TO DETERMINE THE LOT NUMBER OR CATALOG THROUGH THE PHOTOS PROVIDED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED 'RIGHT IMPLANT INTRACAPSULAR RUPTURE' AND 'SEVERAL BILATERAL MICROCYSTS.' THIS RELATES TO THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED 'RIGHT IMPLANT INTRACAPSULAR RUPTURE.' RECORD RELATES TO RIGHT SIDE. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED 'RIGHT IMPLANT INTRACAPSULAR RUPTURE.' RECORD RELATES TO RIGHT SIDE. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860743 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3042301 05060191601597

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention