BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED TEXTURED FORMED IMPLANT

    MDR report key: 8822944 · Received July 23, 2019

    Report

    Report Number
    MW5088349
    Event Type
    Injury
    Date Received
    July 23, 2019
    Date of Event
    April 17, 2019
    Report Date
    July 16, 2019
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPEATED SEROMA RESULTING IN IMPLANT REMOVAL AND REPLACEMENT UNDER DURESS. ON (B)(6) IMPLANTS PLACED AFTER DOUBLE MASTECTOMY. ON (B)(6) 2019 HAD PRONOUNCED SWELLING RT BREAST. ON (B)(6) 2019 RADIOLOGIST WITH SONOGRAM DRAINED 250 CC YELLOW FLUID AND TESTED NO CD-30. ON (B)(6) 2019 SWELLING RETURNED LARGER. ON (B)(6) 2019 RADIOLOGIST DRAINED 410 CC SAME APPEARANCE. TESTED- NO CD-30; ON (B)(6) 2019 SWELLING RETURNED. ON (B)(6) 2019 RADIOLOGIST DRAINED "FOR COMFORT." NOT TESTED FOR CD-30. ON (B)(6) 2019 SURGERY TO REMOVE TEXTURED IMPLANTS AND CAPSULES. LIQUID TESTED AND FOUND 6% CD-30. TISSUE TESTED AND FOUND TO BE GRANULOMA. NEW IMPLANTS RECEIVED, ALLERGAN NATRELLE INSPIRA COHESIVE SCX 750 (L) AND SCX 800 (R). "SIGBIC" PHOTOGRAPHS OF EXPLANTED TEXTURED IMPLANTS AND CAPSULE SHOW IMPLANTS WITH AREAS OF MISSING TEXTURE ESPECIALLY ON RIGHT SIDE. NO MFR WARRANTY CLAIM PROCESSED BY HOSPITAL FOR CD-30 + OR PROCEDURES TO REMOVE FLUID. BILLING CODES DO NOT REFLECT EXCHANGE OF IMPLANTS UNDER DURESS FOR SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612587 STYLE 410 COHESIVE SILICONE GEL FILLED TEXTURED FORMED IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN FX410775 2816713
    612588 STYLE 410 COHESIVE SILICONE GEL FILLED TEXTURED FORMED IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN FX410775 2816713

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| O| R