BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 13262023 · Received January 14, 2022

    Report

    Report Number
    2246315-2022-00001
    Event Type
    Injury
    Date Received
    January 14, 2022
    Report Date
    January 18, 2022
    Manufacturer
    GENZYME CORPORATION(RIDGEFIELD)
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SANOFI COMPANY COMMENT ON 11-JAN-2022: THIS CASE INVOLVES ADULT FEMALE PATIENT WHO EXPERIENCED COULDN'T STAND UP, HAD CRAMPS AND MUST BE ALLERGIC WHILE BEING TREATED WITH HYLAN G-F 20, SODIUM HYALURONATE (SYNVISC). BASED ON THE LIMITED INFORMATION PROVIDED REGARDING THIS CASE, CAUSAL ROLE OF THE COMPANY SUSPECT PRODUCT CANNOT BE EXCLUDED. CASE WILL BE RE-EVALUATED POST FURTHER UPDATE ON THE PATIENT'S UNDERLYING DISEASE CONDITIONS, PAST MEDICAL AND DRUG HISTORY, CONCURRENT ILLNESSES AND CONCOMITANT MEDICATIONS.

    Additional Manufacturer Narrative · 0

    SANOFI COMPANY COMMENT ON (B)(6) 2022: THIS CASE INVOLVES ADULT FEMALE PATIENT WHO EXPERIENCED COULDN'T STAND UP, HAD CRAMPS AND MUST BE ALLERGIC WHILE BEING TREATED WITH HYLAN G-F 20, SODIUM HYALURONATE [SYNVISC]. BASED ON THE LIMITED INFORMATION PROVIDED REGARDING THIS CASE, CAUSAL ROLE OF THE COMPANY SUSPECT PRODUCT CANNOT BE EXCLUDED. CASE WILL BE RE-EVALUATED POST FURTHER UPDATE ON THE PATIENT'S UNDERLYING DISEASE CONDITIONS, PAST MEDICAL AND DRUG HISTORY, CONCURRENT ILLNESSES AND CONCOMITANT MEDICATIONS.

    Description of Event or Problem · 0

    CRAMPS, COULDN'T STAND UP, (DIFFICULTY IN STANDING). MUST BE ALLERGIC (ALLERGIC REACTION TO DRUG) (BURNING SENSATION), (ARTHRALGIA AGGRAVATED). CASE NARRATIVE: INITIAL INFORMATION RECEIVED ON (B)(6) 2022 FROM (B)(6) REGARDING AN UNSOLICITED VALID SERIOUS CASE RECEIVED FROM A PATIENT. THIS CASE INVOLVES ADULT FEMALE PATIENT WHO EXPERIENCED COULDN'T STAND UP, HAD CRAMPS AND MUST BE ALLERGIC WHILE BEING TREATED WITH HYLAN G-F 20, SODIUM HYALURONATE (SYNVISC). THE PATIENT'S PAST MEDICAL HISTORY INCLUDED KNEE PAIN. THE PATIENT'S PAST MEDICAL TREATMENT(S) INCLUDED CORTISONE INJECTION, THAT THE PATIENT USED FOR 2 YEARS, EVERY 4 TO 5 MONTHS. THE PATIENT'S PAST VACCINATION(S) AND FAMILY HISTORY WERE NOT PROVIDED. ON AN UNKNOWN DATE, THE PATIENT STARTED TAKING HYLAN G-F 20, SODIUM HYALURONATE [SYNVISC] (STRENGTH, FORM, DOSAGE, FREQUENCY, ROUTE, BATCH NUMBER, EXPIRATION DATE AND INDICATION: UNKNOWN). THE PATIENT'S DOCTOR DECIDED TO START THE MEDICATION AND 1 DAY LATER UNFORTUNATELY, AN INCREDIBLE PAIN WENT THROUGH THE PATIENT'S KNEE, A BURNING LIKE THERE WERE 20 NEEDLES IN THE PATIENT'S KNEE (BURNING SENSATION), CRAMPS (MUSCLE SPASMS),THE PATIENT COULD NOT STAND UP (DYSSTASIA), IT WAS UNBEARABLE BUT THE PATIENT ENDURED IT FOR 24 HRS AND MENTIONED THAT IT WAS SO MUCH MORE PAINFUL THAN THE KNEE PAIN THE PATIENT HAD BEFORE CALLING THE DOCTOR URGENTLY, WHO GAVE HIM A SHOT OF CORTISONE TO RELIEVE THE PAIN AND MENTIONED THAT MAY BE THE PATIENT WAS ALLERGIC (DRUG HYPERSENSITIVITY). FIRST TIME PRODUCT USED : YES. ACTION TAKEN WAS NOT APPLICABLE. THE PATIENT WAS TREATED WITH CORTISONE FOR ALL THE EVENTS. AT TIME OF REPORTING, THE OUTCOME WAS UNKNOWN FOR ALL THE EVENTS.

    Description of Event or Problem · 0

    CRAMPS [CRAMPS], COULDN'T STAND UP [DIFFICULTY IN STANDING] , MUST BE ALLERGIC [ALLERGIC REACTION TO DRUG] ([BURNING SENSATION], [ARTHRALGIA AGGRAVATED]), CASE NARRATIVE: INITIAL INFORMATION RECEIVED ON 04-JAN-2022 FROM CANADA REGARDING AN UNSOLICITED VALID SERIOUS CASE RECEIVED FROM A PATIENT. THIS CASE INVOLVES ADULT FEMALE PATIENT WHO EXPERIENCED COULDN'T STAND UP, HAD CRAMPS AND MUST BE ALLERGIC WHILE BEING TREATED WITH HYLAN G-F 20, SODIUM HYALURONATE [SYNVISC]. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED KNEE PAIN. THE PATIENT'S PAST MEDICAL TREATMENT(S) INCLUDED CORTISONE INJECTION, THAT THE PATIENT USED FOR 2 YEARS, EVERY 4 TO 5 MONTHS. THE PATIENT'S PAST VACCINATION(S) AND FAMILY HISTORY WERE NOT PROVIDED. ON AN UNKNOWN DATE, THE PATIENT STARTED TAKING HYLAN G-F 20, SODIUM HYALURONATE [SYNVISC] (STRENGTH, FORM, DOSAGE, FREQUENCY, ROUTE, BATCH NUMBER, EXPIRATION DATE AND INDICATION: UNKNOWN). THE PATIENT'S DOCTOR DECIDED TO START THE MEDICATION AND 1 DAY LATER UNFORTUNATELY, AN INCREDIBLE PAIN WENT THROUGH THE PATIENT'S KNEE, A BURNING LIKE THERE WERE 20 NEEDLES IN THE PATIENT'S KNEE (BURNING SENSATION), CRAMPS (MUSCLE SPASMS),THE PATIENT COULD NOT STAND UP (DYSSTASIA), IT WAS UNBEARABLE BUT THE PATIENT ENDURED IT FOR 24 HRS AND MENTIONED THAT IT WAS SO MUCH MORE PAINFUL THAN THE KNEE PAIN THE PATIENT HAD BEFORE CALLING THE DOCTOR URGENTLY, WHO GAVE HIM A SHOT OF CORTISONE TO RELIEVE THE PAIN AND MENTIONED THAT MAY BE THE PATIENT WAS ALLERGIC (DRUG HYPERSENSITIVITY). FIRST TIME PRODUCT USED : YES. ACTION TAKEN WAS NOT APPLICABLE. THE PATIENT WAS TREATED WITH CORTISONE FOR ALL THE EVENTS. AT TIME OF REPORTING, THE OUTCOME WAS UNKNOWN FOR ALL THE EVENTS. UPON ON INTERNAL REVIEW, (B)(4) (TO BE DELETED) WAS IDENTIFIED TO BE DUPLICATE OF (B)(4), (TO BE RETAINED). HENCE, ALL THE INFORMATION FROM THE (B)(4), (TO BE DELETED) HAS TO BE MERGED IN THE (B)(4), PREPARED FOR DELETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754955 SYNVISC MOZ MOZ GENZYME CORPORATION(RIDGEFIELD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention