BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIMO SAN

    MDR report key: 8377776 · Received February 28, 2019

    Report

    Report Number
    1216677-2019-00105
    Event Type
    Injury
    Date Received
    February 28, 2019
    Date of Event
    February 13, 2019
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGD
    PMA / PMN Number
    E216669
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT STATES THEY ARE ALLERGIC TO THE TRIM-SAN JELLY. ADVISED SHE PURCHASED AT (B)(6). PATIENT WAS ADVISED TO CONTACT THEIR MEDICAL PROVIDER TO ALERT OF ANY ADVERSE EFFECTS. PATIENT STATES THEY HAVE NO INTEREST IN DOING SO. PATIENT ONLY LOOKING FOR REIMBURSEMENT OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171153 TRIMO SAN TRIMO SAN HGD COOPERSURGICAL, INC. MX5030

    Patients

    Seq Age Sex Outcome Treatment
    1 Other