BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 10585211 · Received September 25, 2020

    Report

    Report Number
    9617229-2020-16223
    Event Type
    Injury
    Date Received
    September 25, 2020
    Report Date
    January 2, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: A.2., G.3.

    Description of Event or Problem · 0

    THE DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    PATIENT REPORTED LEFT "RECENT LEFT SIDED PAIN MASTITIS" AND "SOME PERI IMPLANT COLLECTION INFEROMEDIALLY". THE DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE EVENT OF SEROMA 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 ALLERGAN IS NOT REQUESTING THE DEVICE RETURN AT THIS TIME DUE TO GLOBAL SAFETY CONCERNS ASSOCIATED WITH COVID-19.

    Description of Event or Problem · 1

    PATIENT REPORTED LEFT "RECENT LEFT SIDED PAIN MASTITIS" AND "SOME PERI IMPLANT COLLECTION INFEROMEDIALLY". THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1054390 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2371998

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention