BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 9016640 · Received September 12, 2019

    Report

    Report Number
    9617229-2019-14348
    Event Type
    Injury
    Date Received
    September 12, 2019
    Date of Event
    April 17, 2019
    Report Date
    September 12, 2019
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    10888628003040
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN RESPONSE TO FDA REPORT NUMBER MW5088349. 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. REASON FOR REOPERATION: GRANULOMA AND SEROMA. THE EVENTS OF GRANULOMA AND SEROMA ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    PATIENT REPORTED ¿REPEATED SEROMA RESULTING IN IMPLANT REMOVAL AND REPLACEMENT UNDER DURESS, IMPLANTS PLACED AFTER DOUBLE MASTECTOMY. 2019 HAD PRONOUNCED SWELLING RT BREAST. ON (B)(6) 2019 RADIOLOGIST WITH SONOGRAM DRAINED 250 CC YELLOW FLUID AND TESTED NO CD-30. ON (8)(6) 2019 SWELLING RETURNED LARGER. ON (B)(6) 2019 RADIOLOGIST DRAINED 410 CC SAME APPEARANCE. TESTED- NO CD-30; ON (8)(6) 2019 SWELLING RETURNED. ON (8)(6) 2019 RADIOLOGIST DRAINED "FOR COMFORT." NOT TESTED FOR C0-30. ON (8)(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 C0-30 +OR PROCEDURES TO REMOVE FLUID. BILLING CODES DO NOT REFLECT EXCHANGE OF IMPLANTS UNDER DURESS FOR SURGERY.¿ THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797185 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2816713 10888628003040

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention