BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GELSYN-3

    MDR report key: 9329277 · Received November 15, 2019

    Report

    Report Number
    3008280916-2019-01318
    Event Type
    Injury
    Date Received
    November 15, 2019
    Report Date
    November 12, 2019
    Manufacturer
    IBSA FARMACEUTICI ITALIA SRL
    Product Code
    MOZ
    UDI-DI
    08033638951057
    PMA / PMN Number
    P110005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS SPONTANEOUS SERIOUS REPORT RECEIVED FROM A PHYSICIAN BY BIOVENTUS (REF. (B)(4)) ON (B)(6) 2019 AND MERGED WITH THE FOLLOW-UP INFORMATION RECEIVED ON 07NOV2019 THROUGH THE SALES REP. DESCRIBES THE OCCURRENCE OF ANAPHYLACTIC SHOCK, IN A PATIENT WHO WAS PRESCRIBED GELSYN-3 (HYALURONATE SODIUM 0.84 %) INJECTION, FOR UNKNOWN INDICATION. ON (B)(6) A (B)(6) MALE PATIENT RECEIVED A GELSYN INJECTION (BATCH N. NA) IN THE RIGHT KNEE. SEVERAL DAYS LATER (ON AN UNKNOWN DATE), HE EXPERIENCED AN ANAPHYLACTIC SHOCK. THE PATIENT WAS SEEN AT THE EMERGENCY ROOM FOR EPISODE OF ANAPHYLAXIS, THAT RESOLVED IMMEDIATELY AFTER THE ER TREATMENT. NO CONCOMITANT DRUGS WERE REPORTED. PRIOR USE OF SUPARTZ (HYALURONIC ACID) LAST YEAR WITH NO ISSUES NOTED. MEDICATION CHANGE DUE TO INSURANCE. MEDICAL HISTORY: PROSTATE, HIGH BLOOD PRESSURE. THE PATIENT'S ALLERGIST STATED IT COULD HAVE/MAY HAVE BEEN RELATED TO INJECTION. IBSA COMMENT: ANAPHYLACTIC SHOCK IS A SERIOUS CONDITION. FOLLOW-UP CLARIFIED THAT THE PATIENT WENT TO THE EMERGENCY ROOM WHERE HE RECEIVED AN APPROPRIATE TREATMENT, SO THE ADVERSE EVENT HAS BEEN MEDICALLY CONFIRMED. THE CASE IS EVALUATED AS SERIOUS (MEDICALLY SIGNIFICANT), UNLISTED AND UNLIKELY RELATED BECAUSE THE REACTION OCCURRED FEW DAYS AFTER THE INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1123850 GELSYN-3 SODIUM HYALURONATE FOR INJECTION MOZ IBSA FARMACEUTICI ITALIA SRL 08033638951057

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other