BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 20 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 3181456 · Received June 14, 2013

    Report

    Report Number
    2024601-2013-00502
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    UDI-DI
    10888628001664
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT ON 12/03/2013. REVIEW OF DEVICE LABELING: THERE WERE NO CASES REPORTED OF RAYNAUD'S PHENOMENON IN THE ALLERGAN CORE STUDY FOR SILICONE IMPLANTS.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE LABELING REVIEWED: THERE WERE NO REPORTED EVENTS OF LYMPHOMA/ALCL, FOR PATIENTS IN THE CORE STUDY, IN THE LABELING FOR SILICONE IMPLANTS.

    Description of Event or Problem · 1

    PATIENT REPORTS NON-HODGKINS LYMPHOMA ON HER ANNUAL QUESTIONNAIRE FOR THE BREAST IMPLANT FOLLOW UP STUDY. EVENT NOT SIDE SPECIFIC. SEVERAL ATTEMPTS WERE MADE TO DETERMINE THE TYPE OF LYMPHOMA AND ANY DEVICE RELATEDNESS BY THE DIAGNOSING PHYSICIAN, BUT THEY WERE UNABLE TO PROVIDE ANY INFORMATION OTHER THAN THE PATIENT HAD NON-HODGKINS LYMPHOMA. THIS EVENT IS REPORTED AGAINST THE RIGHT SIDE. SEE MFR 2024601-2013-00504 FOR THE LEFT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: PATIENT REPORTED RAYNAUD'S PHENOMENON.

    Description of Event or Problem · 1

    SEE MFR REPORT # 2024601-2013-00504 FOR THE LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272066 STYLE 20 SILICONE GEL FILLED BREAST IMPLANT FTR ALLERGAN NA 1808425 10888628001664

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NO INFORMATION