BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 15 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 14338146 · Received May 9, 2022

    Report

    Report Number
    9617229-2022-07337
    Event Type
    Injury
    Date Received
    May 9, 2022
    Date of Event
    February 18, 2022
    Report Date
    November 7, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D9, G1, H3, H6. DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF RUPTURE WAS RECEIVED ON SEPTEMBER 21, 2022 WITH LOT NUMBER 2070696. BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: RUPTURE: OBSERVED, OPENING WITH NON-PENETRATING NICKS ASSESSED AS TO SURGICAL IMPACT (SHELL THICKNESS WAS WITHIN SPECIFICATION), AROUND THE OPENING HAVE NON-PENETRATING NICKS. ADDITIONAL OBSERVATIONS: CREASE FLAT IN THE SURFACE OF THE SELL. NO FURTHER ACTIONS ARE REQUIRED AS THE DEVICE WAS IMPLANTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5, D.6.B, H6.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "A RIGHT SIDE RUPTURE." DEVICE REMAINS IMPLANTED. RIGHT SIDE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "A RIGHT SIDE RUPTURE." THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1840388 STYLE 15 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2070696

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention