BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 110 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 13476709 · Received February 7, 2022

    Report

    Report Number
    9617229-2022-00945
    Event Type
    Injury
    Date Received
    February 7, 2022
    Date of Event
    January 11, 2022
    Report Date
    October 13, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 RETURNED DEVICE IDENTIFIED: UNDERWEIGHT AND BROKEN SHELL. A MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED: SHARP BROKEN ON POSTERIOR. A DIMENSION MEASUREMENT IN THE SHELL WAS PERFORMED WHICH IDENTIFY THE THICKNESS WITHIN SPECIFICATION. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: - SHARP BROKEN ON POSTERIOR ASSESSED AS UNIDENTIFIED (TEAR) OPENING.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED.

    Additional Manufacturer Narrative · 0

    VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: A BROKEN DEVICE, WITH LOT NUMBER 2232068 AND LABELED RIGHT SIDE DEVICE ANALYSIS PERFORMED THROUGH PHOTOGRAPHS, DUE TO THE IMPOSSIBILITY TO PERFORM MICROSCOPIC ANALYSIS IT IS NOT POSSIBLE TO DETERMINE THE MOST LIKELY FAILURE MODE.

    Description of Event or Problem · 0

    PATIENT REPORTED A RIGHT SIDE "TEXTURED PRODUCT" AND "RUPTURE." DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    PATIENT REPORTED A RIGHT SIDE "TEXTURED PRODUCT" AND "RUPTURE." DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    PATIENT REPORTED A RIGHT SIDE "TEXTURED PRODUCT" AND "RUPTURE." DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757420 STYLE 110 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2232068
    927792 STYLE 110 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2232068

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention