BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIENTRA OPUS SILICONE GEL BREAST IMPLANT

    MDR report key: 13343637 · Received January 25, 2022

    Report

    Report Number
    1651189-2022-02005
    Event Type
    Injury
    Date Received
    January 25, 2022
    Date of Event
    November 4, 2021
    Report Date
    January 25, 2022
    Manufacturer
    SIENTRA INC.
    Product Code
    FTR
    PMA / PMN Number
    P070004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN EXPLANTED AND DISPOSED OF. WE WILL NOT BE ABLE TO PERFORM DEVICE ANALYSIS ON THIS DEVICE.

    Description of Event or Problem · 0

    RIGHT IMPLANT RUPTURED, DISCOVERED DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1624175 SIENTRA OPUS SILICONE GEL BREAST IMPLANT SILICONE GEL BREAST IMPLANT FTR SIENTRA INC. 10621XXXHP 100909867

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Required Intervention