BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GELSYN

    MDR report key: 19353052 · Received May 20, 2024

    Report

    Report Number
    3009595577-2024-00002
    Event Type
    Injury
    Date Received
    May 20, 2024
    Date of Event
    April 11, 2024
    Report Date
    May 20, 2024
    Manufacturer
    IBSA FARMACEUTICI ITALIA SRL
    Product Code
    MOZ
    UDI-DI
    08033638951057
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: B4 CORRECTED WITH INITIAL DATE REPORTED TO THE FDA.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT WAS DIAGNOSED WITH AN INFECTION AFTER RECEIVING A GELSYN INJECTION. THE PATIENT HAD THEIR FIST INJECTION ON (B)(6) 2024. TWO DAYS POST INJECTION THE PATIENT EXPERIENCED SWELLING WITHOUT SIGNS OF INFECTION AT THE INJECTION SITE. A FOLLOW UP WITH THE PHYSICIAN WAS CONDUCTED BY THE PAITENT, THE PHYSICIAN ADVISED THE PATIENT TO APPLY COLD COMPRESS AND IF SYMPTOMS DID NOT IMPROVE, SEEK URGENT MEDICAL CARE. THREE DAYS POST INJECTION THE PATIENT WENT TO THE URGENT CARE WHERE CULTURES WERE TAKEN AND TESTED POSITIVE FOR STREP. THE PATIENT UNDERWENT THREE KNEE DRAINING PROCEDURES AND WAS TREATED WITH ANTIBIOTICS. PATIENT WAS ADMITTED TO THE HOSPITAL TO UNDERGO A WASHOUT PROCEDURE AND ADDITIONAL ANTIBIOTIC TREATMENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND REPORTED AS IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1616310 GELSYN HYALURONIC ACID MOZ IBSA FARMACEUTICI ITALIA SRL N/A A10438 08033638951057

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention| H