BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GELSYN-3 INJ 16.8/2ML

    MDR report key: 8403471 · Received March 7, 2019

    Report

    Report Number
    MW5084753
    Event Type
    Injury
    Date Received
    March 7, 2019
    Date of Event
    February 28, 2019
    Report Date
    March 4, 2019
    Manufacturer
    IBSA FARMACEUTICI ITALIA SRL
    Product Code
    MOZ
    UDI-DI
    89130311101
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD FIRST GEL-SYN INJECTION ON (B)(6) 2019. PATIENT SAID SHE WAS VERY TIRED THE REST OF THE DAY AND WENT TO BED EARLY. THE NEXT DAY SHE WAS STILL VERY TIRED AND FELT ¿OFF¿. THE PATIENT DESCRIBED THIS AS ACHES AND PAINS, FLU SYMPTOMS. FEVER THAT WENT UP TO 99.9 DEGREES F, EXTREME HEADACHE, AND DIZZINESS. THE PATIENT TRIED TO GET IN TOUCH WITH HER DOCTOR, BUT THEY HAVEN¿T CALLED HER BACK. THE PATIENT FEELS BETTER NOW AND FEVER IS GONE. PATIENT SAYS SHE STILL FEELS LIKE SHE DOESN¿T HAVE VERY MUCH ENERGY. PATIENT SAID SHE SHOULD HEAR BACK FROM HER DOCTOR TODAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195025 GELSYN-3 INJ 16.8/2ML ACID, HYALURONIC, INTRAARTICULAR MOZ IBSA FARMACEUTICI ITALIA SRL 89130311101

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR