BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 10588341 · Received September 25, 2020

    Report

    Report Number
    9617229-2020-15279
    Event Type
    Injury
    Date Received
    September 25, 2020
    Report Date
    December 1, 2020
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED THE DEVICE WAS SEEN RUPTURED. DEVICE PATCH WITH LOT NUMBER: 2926308. DEVICE ANALYSIS PERFORMED THROUGH PHOTOGRAPHS, DUE TO THE IMPOSSIBILITY TO PERFORM MICROSCOPIC ANALYSIS IT IS NOT POSSIBLE TO DETERMINE THE MOST LIKELY FAILURE MODE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D.7.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED TEXTURED TO SMOOTH IMPLANT REPLACEMENT AND RUPTURE ON RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED TEXTURED TO SMOOTH IMPLANT REPLACEMENT AND RUPTURE ON RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

    Additional Manufacturer Narrative · 1

    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: TEXTURED TO SMOOTH EXCHANGE.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED TEXTURED TO SMOOTH IMPLANT REPLACEMENT AND RUPTURE ON RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053054 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2926308

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention