BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 45 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 16158334 · Received January 13, 2023

    Report

    Report Number
    9617229-2022-24276
    Event Type
    Injury
    Date Received
    January 13, 2023
    Date of Event
    December 20, 2022
    Report Date
    March 1, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    10888628002074
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    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. 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: BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: RUPTURE: OBSERVED OPENING ON ANTERIOR SIDE ASSESSED AS SURGICAL DAMAGE ADDITIONAL OBSERVATIONS: OBSERVED NON PENETRATING NICKS ON THE DEVICE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE RUPTURE. HEALTHCARE PROFESSIONAL LATER REPORTED ¿HOLE NONSPECIFIC¿ VIA AN RGA FORM. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE RUPTURE. HEALTHCARE PROFESSIONAL LATER REPORTED ¿HOLE NONSPECIFIC¿ VIA AN RGA FORM. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528107 STYLE 45 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 45-400 2961698 10888628002074

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention