BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIENTRA OPUS SILICONE GEL BREAST IMPLANT

    MDR report key: 15120708 · Received July 28, 2022

    Report

    Report Number
    1651189-2022-02895
    Event Type
    Injury
    Date Received
    July 28, 2022
    Date of Event
    January 1, 2015
    Report Date
    July 28, 2022
    Manufacturer
    SIENTRA INC.
    Product Code
    FTR
    PMA / PMN Number
    P070004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SIENTRA COMPLAINT #: (B)(4). AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. SIENTRA WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    SIENTRA COMPLAINT#: (B)(4). ADDITIONAL INFORMATION: MDR CREATED IN RESPONSE TO MW#5110852 RECEIVED THROUGH THE FDA'S MEDWATCH PROGRAM FROM THE CUSTOMER. SIENTRA WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    PATIENT-DEVICE INCOMPATIBILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2320749 SIENTRA OPUS SILICONE GEL BREAST IMPLANT SILICONE GEL BREAST IMPLANT FTR SIENTRA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention