BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENVISC 850

    MDR report key: 10767514 · Received October 31, 2020

    Report

    Report Number
    3011402886-2020-00001
    Event Type
    Injury
    Date Received
    October 31, 2020
    Date of Event
    September 28, 2020
    Report Date
    October 2, 2020
    Manufacturer
    MEIJI PHARMA SPAIN
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    SC, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN THIS CASE WAS DISPOSED OF BY THE HCP AND NOT AVAILABLE FOR A REVIEW BY THE MANUFACTURER. GENVISC 850 LOT P-3 WAS MANUFACTURED AND RELEASED ACCORDING TO APPLICABLE PROCEDURES AND SPECIFICATIONS. THE FINISHED PRODUCT RELEASE CERTIFICATE INDICATES THE PRODUCT MET ALL ACCEPTABILITY SPECIFICATIONS AND IS STERILE.

    Description of Event or Problem · 1

    ON 10/7/2020 THE GENVISC 850 CALL CENTER WAS NOTIFIED BY EMAIL THAT A PATIENT HAD EXPERIENCED SEVERE PAIN AND SWELLING AFTER AN INJECTION. AE ASSESSOR SPOKE WITH THE HEALTH CARE PROVIDER (HCP) WHO PROVIDED THE INFORMATION FOR THE NURSE PRACTITIONER (NP) WHO CARED FOR THIS PATIENT. THE HCP REPORTED THE PATIENT HAD SEVERE SWELLING OF THE KNEE SO THE PATIENT COULD NOT WALK (MOBILITY ISSUES) AFTER THE 4TH RIGHT KNEE GENVISC850 INJECTION IN COMBINATION WITH PLATELET-RICH PLASMA (PRP) THE WEEK OF (B)(6) 2020. PAIN LEVEL WAS NOT REPORTED. MEDICAL HISTORY INCLUDES RECEIVING 5 LEFT KNEE GENVISC 850 INJECTIONS WITH NO PROBLEMS AND 3 RIGHT KNEE INJECTIONS OF GENVISC 850 IN COMBINATION WITH PRP THERAPY INJECTIONS WITH NO PROBLEMS. THE HCP REPORTS THE PROCEDURE FOR GIVING A GENVISC 850 INJECTION INCLUDES CLEANING THE AREA WITH BETADINE SOLUTION, APPLYING AN ANALGESIC TOPICAL SPRAY, AND PERFORMING FLUOROSCOPY UTILIZING A RADIOPAQUE CONTRAST AGENT FROM A MULTI-USE VIAL. THE NEXT DAY AFTER THE 4TH GENVISC 850 RIGHT KNEE INJECTION THE PATIENT PHONED THE NP AND REPORTED SEVERE SWELLING THAT CAUSED THE PATIENT NOT TO BE ABLE TO WALK (MOBILITY ISSUES), NO FEVER. WHEN THE PATIENT RETURNED TO THE CLINIC SYNOVIAL FLUID WAS REMOVED FROM THE KNEE. THE SYNOVIAL FLUID WAS SENT TO THE LAB AND TESTED NEGATIVE FOR ANY INFECTION. THE PATIENT WAS DIAGNOSED WITH INFLAMMATION AND PRESCRIBED PREDNISONE. THE PATIENT IMPROVED WITHIN THE WEEK. (B)(6) 2020. IT IS UNKNOWN IF THE GENVISC 850 OR ANY COMPONENT OF THE ADMINISTRATION PROCEDURE INCLUDING THE USE OF A MULTI-USE VIAL MAY HAVE CONTRIBUTED TO THE AE. THE ASSOCIATION OF THE SWELLING, WHICH CONTRIBUTED TO THE DECREASED MOBILITY, WITH THE GENVISC 850 OR ANY COMPONENT OF THE ADMINISTRATION PROCEDURE INCLUDING THE USE OF A MULTI-USE VIAL AND THE PRP GIVEN SIMULTANEOUSLY IS UNKNOWN. HOWEVER, DUE TO THE TEMPORAL SEQUENCE OF THE SWELLING AND DECREASED MOBILITY AFTER THE INJECTION OF GENVISC 850 AND THE PRP AN ASSOCIATION IS PLAUSIBLE. THIS CASE IS BEING REPORTED AS SERIOUS BECAUSE IT REQUIRED INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232069 GENVISC 850 ACID, HYALURONIC, INTRAARTICULAR MOZ MEIJI PHARMA SPAIN 50653-0006-01 P-3

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention