BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 3040117 · Received April 3, 2013

    Report

    Report Number
    2024601-2013-00292
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 5, 2010
    Report Date
    March 5, 2013
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A 410 DEVICE LABELING (PIVOTAL STUDY) ADDRESSES THESE REPORTED EVENTS: SEROMA: 1.1%. CREASE/FOLDING: 1.1. VISIBILITY /PALPABILITY: 1.4%. DEVICE LABELING DESCRIBES THESE ADVERSE EVENTS AS FOLLOWS: ADDITIONAL COMPLICATIONS: SEROMA: "AFTER BREAST IMPLANT SURGERY THE FOLLOWING MANY OCCUR AND/OR PERSIST, WITH VARYING INTENSITY AND/OR FOR A VARYING LENGTH OF TIME: PAIN, HEMATOMA/SEROMA, ETC." CREASE/FOLD AND VISIBILITY PALPABILITY: "COSMETIC DISSATISFACTION - PATIENTS SHOULD BE INFORMED THAT DISSATISFACTION WITH COSMETIC RESULTS RELATED TO SUCH THINGS AS UNANTICIPATED CONTOUR, IMPLANT PALPABILITY MAY OCCUR."

    Description of Event or Problem · 1

    THE PATIENT REPORTED A RIGHT SIDE SILICONE IMPLANT THAT HAS "PUCKERING DUE TO TWO FOLDS IN THE IMPLANT AND HARDENING." FOLLOW-UP WITH THE PHYSICIAN INDICATES "FLUID AROUND THE DEVICE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136840 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT FTR ALLERGAN NA 1263525

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention