BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 115 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 9770584 · Received February 28, 2020

    Report

    Report Number
    9617229-2020-03323
    Event Type
    Injury
    Date Received
    February 28, 2020
    Report Date
    April 15, 2020
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT SEROMA-LATE WAS RECEIVED ON MAR 03, 2020 WITH LOT NUMBER 2040165. VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: WEIGHT TO THE SPEC, CREASE FOLD, DEFORMATION, WHITE PARTICLES. CLOUDY AND BUBBLES WERE OBSERVED AFTER AUTOCLAVE DISINFECTION PROCESS. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: - NO ISSUES FOUND RELATED WITH THE MANUFACTURING PROCESS. ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D.10, H.3, H.6

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED SEROMA-LATE ON THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.

    Additional Manufacturer Narrative · 1

    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. THE EVENT OF SEROMA-LATE IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. 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: SEROMA-LATE.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED SEROMA-LATE ON THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235510 STYLE 115 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2040165

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention