BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIENTRA OPUS SILICONE GEL BREAST IMPLANT

    MDR report key: 9826311 · Received March 12, 2020

    Report

    Report Number
    1651189-2020-00183
    Event Type
    Injury
    Date Received
    March 12, 2020
    Date of Event
    February 14, 2020
    Report Date
    March 12, 2020
    Manufacturer
    SIENTRA, INC.
    Product Code
    FTR
    PMA / PMN Number
    P070004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OFF LABEL USAGE OF SINGLE USE DEVICE IS NOT CONDONED NOR ENCOURAGED BY SIENTRA, INC.

    Description of Event or Problem · 1

    PATIENT DIAGNOSED WITH UNILATERAL CAPSULAR CONTRACTURE, BAKER GRADE 3. LEFT SIDE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290836 SIENTRA OPUS SILICONE GEL BREAST IMPLANT SILICONE GEL BREAST IMPLANT FTR SIENTRA, INC. 10621-XXXMP

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention