BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC ONE

    MDR report key: 7348437 · Received March 19, 2018

    Report

    Report Number
    2246315-2018-00398
    Event Type
    Injury
    Date Received
    March 19, 2018
    Date of Event
    November 1, 2017
    Report Date
    August 26, 2020
    Manufacturer
    GENZYME CORPORATION(RIDGEFIELD)
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SANOFI COMPANY COMMENT DATED 8-MAR-2018: THIS CASE CONCERNS A PATIENT WHO RECEIVED SYNVISC ONE INJECTION AND LATER EXPERIENCED DIFFICULTY IN STANDING AND WAS BEDRIDDEN. BASED UPON THE INFORMATION AVAILABLE, THE CAUSAL ROLE OF THE PRODUCT CANNOT BE DENIED FOR THE OCCURRENCE OF EVENTS. HOWEVER, THERE IS NO INFORMATION REGARDING THE TECHNIQUE OF INJECTION AND WHETHER ASEPTIC CONDITIONS WERE MAINTAINED DURING THE INJECTION. FURTHER INFORMATION REGARDING PATIENT'S CURRENT CLINICAL PRESENTATION, MEDICAL HISTORY, CONCOMITANT MEDICATIONS AND OTHER RISK FACTORS PRECLUDES THE COMPLETE MEDICAL CASE ASSESSMENT.

    Description of Event or Problem · 1

    DIFFICULTY STANDING [DYSSTASIA]. TO STAY IN BED [BEDRIDDEN]. SEVERE PAIN [KNEE PAIN]. CASE NARRATIVE: CASE WAS INITIALLY SUBMITTED VIA SANOFI LEGACY DATABASE AND IS NOW BEING RE-DISTRIBUTED TO FDA AT THEIR REQUEST. THIS SPONTANEOUS CASE FROM UNITED STATES WAS RECEIVED ON 08-MAR-2018 FROM PATIENT VIA HEALTH AUTHORITY. THIS CASE CONCERNS FEMALE PATIENT (AGE: UNKNOWN) WHO INITIATED TREATMENT WITH SYNVISC ONE AND AFTER A FEW HOURS HAD DIFFICULTY STANDING, HAD TO STAY IN BED AND HAD SEVERE PAIN. NO MEDICAL HISTORY, PREVIOUS MEDICATIONS, CONCOMITANT MEDICATIONS AND CONCURRENT CONDITIONS WERE REPORTED. ON AN UNKNOWN DATE IN 2017, PATIENT RECEIVED TREATMENT WITH INTRA ARTICULAR SYNVISC ONE INJECTION (INDICATION, DOSE, FREQUENCY, BATCH/ LOT NUMBER AND EXPIRY DATE: UNKNOWN). ON (B)(6) 2017 FEW HOURS AFTER INJECTION, PATIENT HAD DIFFICULTY STANDING AND SEVERE PAIN THAT CAUSED HER TO STAY IN BED FOR A WEEK. CORRECTIVE TREATMENT: NOT REPORTED FOR ALL EVENTS OUTCOME: UNKNOWN FOR ALL EVENTS. SERIOUSNESS CRITERIA: MEDICALLY SIGNIFICANT FOR ALL EVENTS. A PRODUCT TECHNICAL COMPLAINT WAS INITIATED AND THE RESULTS FOR THE SAME WERE PENDING. PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT DATED 8-MAR-2018: THIS CASE CONCERNS A PATIENT WHO RECEIVED SYNVISC ONE INJECTION AND LATER EXPERIENCED DIFFICULTY IN STANDING AND WAS BEDRIDDEN. BASED UPON THE INFORMATION AVAILABLE, THE CAUSAL ROLE OF THE PRODUCT CANNOT BE DENIED FOR THE OCCURRENCE OF EVENTS. HOWEVER, THERE IS NO INFORMATION REGARDING THE TECHNIQUE OF INJECTION AND WHETHER ASEPTIC CONDITIONS WERE MAINTAINED DURING THE INJECTION. FURTHER INFORMATION REGARDING PATIENT'S CURRENT CLINICAL PRESENTATION, MEDICAL HISTORY, CONCOMITANT MEDICATIONS AND OTHER RISK FACTORS PRECLUDES THE COMPLETE MEDICAL CASE ASSESSMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194663 SYNVISC ONE MOZ MOZ GENZYME CORPORATION(RIDGEFIELD) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| O