BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINOVIAL

    MDR report key: 9979404 · Received April 20, 2020

    Report

    Report Number
    3008280916-2020-00218
    Event Type
    Injury
    Date Received
    April 20, 2020
    Date of Event
    May 17, 2019
    Report Date
    April 17, 2020
    Manufacturer
    IBSA FARMACEUTICI ITALIA SRL
    Product Code
    MOZ
    PMA / PMN Number
    P110005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT DESCRIBES A FOREIGN CASE (IBSA REF. N. (B)(4) RECEIVED FOR A DEVICE (OUS TRADENAME SINOVIAL) THAT IS SIMILAR TO GELSYN-3 APPROVED UNDER PMA P110005.

    Description of Event or Problem · 1

    THIS SERIOUS SPONTANEOUS REPORT WAS RECEIVED FROM LABORATORIES GENEVRIER (REF. NR. (B)(4) ON (B)(6) 2020 DESCRIBES THE OCCURRENCE OF HYPOESTHESIA, MALAISE AND ERYTHEMA, IN A UNKNOWN PATIENT WHO WAS PRESCRIBED SINOVIAL (HYALURONATE SODIUM 0.8 %), INJECTION, 2 ML FOR UNKNOWN INDICATION. DESCRIPTION: (B)(6) 2019: RIGHT KNEE INFILTRATION AROUND 2 P.M. A MONTH BEFORE, THE PATIENT HAD BEEN INFILTRATED IN THE LEFT KNEE WITH THE SAME PRODUCTS, IT WAS THE 3RD INFILTRATION. 1 HOUR LATER THE PATIENT PRESENTED WITH A FEELING OF MALAISE, WITH SIGNIFICANT HEAT, REDNESS OF THE FACE WITHOUT URTICARIAL FLARE THE NEXT DAY. WHILE WASHING SHE FOUND HYPOESTHESIA OF THE RIGHT HEMIFACE, ALL OVER TERRITORY OF V, WITHOUT PARALYSIS OF THE FACIAL NERVE VII, HAVING LASTED APPROXIMATELY 48 HOURS. ASSESSMENT IN EMERGENCY ROOM AND NEURO INTENSIVE CARE WITHOUT PARTICULARITY, WITH AN MRI SCANNER, NORMAL BIOLOGY ELIMINATING A STROKE OR TUMOR PATHOLOGY. POSSIBLE ASSESSMENT FOR INFILTRATION, BUT NEITHER LIKELY NOR CERTAIN. THE DECLARATION WAS MADE DUE TO THE POTENTIAL SEVERITY OF THE NEUROLOGICAL REACTION AND THE LACK OF REPORTING OF THIS SIDE EFFECT WITH THIS PRODUCT. THE PATIENT WAS NOT TAKING ANY CONCOMITANT MEDICATION. THE CASE IS CONSIDERED SERIOUS FOR HOSPITALIZATION. THE PATIENT RECOVERED WITHOUT SEQUALAE. IBSA COMMENT: SERIOUS, UNLISTED, POSSIBLE REACTION TO INFILTRATION DUE TO LACK OF ALTERNATIVE EXPLANATION. HOWEVER THIS COULD BE ALSO A CONCOMITANT SPONTANEOUS EVENT. ON (B)(6) 2020 FOLLOW UP WAS RECEIVED FROM LABORATORIES GENEVRIER: IT IS NOT VERY CLEAR WHETHER ALL THE SYMPTOMS LASTED 48 HOURS OR ONLY THE HYPOESTHESIA. THE CASE WAS REPORTED BY THE CRPV (REGIONAL CENTER OF PV) OF TOULOUSE. IBSA COMMENT: FOLLOW UP INFORMATION DOESN'T CHANGE THE ASSESSMENT, SERIOUS CASE, POSSIBLE, UNLISTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440907 SINOVIAL SODIUM HYALURONATE FOR INJECTION MOZ IBSA FARMACEUTICI ITALIA SRL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization