BEUDAMED
    FDA Adverse Event Injury Summary report: N

    120-260

    MDR report key: 787955 · Received November 7, 2006

    Report

    Report Number
    2024601-2006-00634
    Event Type
    Injury
    Date Received
    November 7, 2006
    Manufacturer
    INAMED CORPORATION - SANTA BARBARA
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OF CAPSULAR CONTRACTURE WAS PREVIOUSLY REPORTED ON EASR. DEVICE LABELING ADDRESSES THE POSSIBLE EVENT OF CAPSULAR CONTRACTURE AS FOLLOWS: "CAPSULAR CONTRACTURE MAY BE MORE COMMON FOLLOWING INFECTION, HEMATOMA, AND SEROMA. IT IS ALSO MORE COMMON WITH SUBGLANDULAR PLACEMENT. SYMPTOMS RANGE FROM FIRMNESS AND MILD DISCOMFORT, TO PAIN, DISTORTION, PALPABILITY OF THE IMPLANT, AND/OR DISPLACEMENT OF THE IMPLANT. ADD'L SURGERY IS NEEDED IN CASES WHERE PAIN AND/OR FIRMNESS IS SEVERE. THIS SURGERY RANGES FROM REMOVAL OF THE IMPLANT CAPSULE TISSUE TO REMOVAL AND POSSIBLE REPLACEMENT OF THE IMPLANT ITSELF. CAPSULAR CONTRACTURE MAY HAPPEN AGAIN AFTER THESE ADD'L SURGERIES."

    Description of Event or Problem · 1

    LEFT SIDE CAPSULAR CONTRACTURE GRADE III.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 120-260 GEL BREAST IMPLANT FTR INAMED CORPORATION - SANTA BARBARA STYLE 120 PO2-123886

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention