BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 3890826 · Received June 4, 2014

    Report

    Report Number
    2246315-2014-56785
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 24, 2014
    Manufacturer
    GENZYME BIOSURGERY
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH GLOBAL PTC NUMBER: (B)(4). THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH RECORD REVIEW WAS NOT POSSIBLE. BASED ON THE LACK OF INFORMATION PROVIDED, NO CAPA WAS REQUIRED. IT WAS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR SPECIFICATION CONFORMANCE PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT WAS IDENTIFIED AND MITIGATED THROUGH THE NCR PROCESS. DATA WAS PERIODICALLY PRESENTED AND REVIEWED BY INDIVIDUALS RESPONSIBLE FOR ASSURING PRODUCT SAFETY. THIS REVIEW HAD NOT INDICATED ANY SAFETY ISSUE. GENZYME BIOSURGERY WOULD CONTINUE TO MONITOR ADVERSE EVENTS TO DETERMINE IF A CAPA WAS REQUIRED. REPORTER CAUSALITY: NOT RELATED TO THE EVENTS OF FEET SWELL AND HURT AND KNEE WAS SWELLING. ADDITIONAL FOLLOW UP WAS RECEIVED ON (B)(6) 2014. NO NEW INFORMATION WAS RECEIVED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2014. PTC RESULTS WERE ADDED AND THE TEXT WAS AMENDED ACCORDINGLY. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2014 FROM THE CONSUMER (NURSE). THE CASE BECAME MEDICALLY CONFIRMED AND THIS CASE INITIALLY CONSIDERED AS NON-SERIOUS WAS UPGRADED TO SERIOUS AS THE PATIENT RECEIVED TREATMENT WITH CORTISONE INJECTIONS FOR THE EVENTS OF FEET SWELL AND HURT AND KNEE WAS SWELLING. THE PATIENT'S CONCURRENT CONDITIONS AND CONCOMITANT MEDICATIONS WERE UPDATED. THE THERAPY DETAILS OF SUSPECT PRODUCT (STOP DATE) WAS UPDATED. THE CORRECTIVE TREATMENT FOR THE EVENTS OF FEET SWELL AND HURT AND KNEE WAS SWELLING WAS ADDED. REPORTER'S CAUSALITY FOR THE EVENTS OF FEET SWELL AND HURT AND KNEE WAS SWELLING WAS ADDED. CLINICAL COURSE WAS UPDATED. TEXT WAS AMENDED ACCORDINGLY. PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT DATED (B)(6) 2014: THE CASE INVOLVES A PATIENT WHO EXPERIENCED FEET SWELL AND FEET HURT WHILST ON SYNVISC. AS PER THE REPORTER, THE CAUSAL RELATIONSHIP WITH THE EVENT OF IS UNLIKELY RELATED WITH SYNVISC. HOWEVER, MORE INFORMATION IS NEEDED FOR BETTER CASE ASSESSMENT.

    Description of Event or Problem · 1

    BASED ON ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2014 RECEIVED FROM THE PATIENT (NURSE HERSELF), THIS CASE INITIALLY CONSIDERED AS NON-SERIOUS WAS UPGRADED TO SERIOUS AS THE PT RECEIVED TREATMENT WITH CORTISONE FOR THE EVENTS OF FEET SWELL AND HURT AND KNEE WAS SWELLING AND THE CASE BECAME MEDICALLY CONFIRMED. THIS UNSOLICITED DEVICE CASE FROM UNITED STATES WAS RECEIVED ON (B)(6) 2014 FROM A CONSUMER (PT). THIS CASE INVOLVES A (B)(6) YEARS OLD FEMALE PT WHOSE FEET SWELL AND HURT, KNEE WAS SWELLING, "TAKEN OUT FLUID SEVERAL TIMES FROM HER KNEE" AND HAD NOT RELIEVED FROM PAIN (SUBTHERAPEUTIC RESPONSE) WHILST RECEIVING TREATMENT WITH SYNVISC. THE PT HAD MEDICAL HISTORY OF BAKER CYST BEHIND KNEE. IT WAS REPORTED THAT THE PT WENT TO EMERGENCY ROOM IN (B)(6) 2013 AND DEEP VEIN THROMBOSIS WAS RULED OUT BUT BAKER CYST BEHIND KNEE WAS FOUND. IT WAS CAUSING A LOT OF PAIN AND SHE COULD NOT WALK. PAST DRUGS AND CONCURRENT CONDITIONS WERE NOT REPORTED. CONCOMITANT MEDICATIONS INCLUDED CORTISONE, THYROID (ARMOUR THYROID) FOR HYPOTHYROIDISM, GLIPIZIDE FOR TYPE DIABETES MELLITUS, LISINOPRIL FOR HYPERTENSION, ESTRADIOL POSTMENOPAUSAL AND TOLTERODINE L-TARTRATE (DETROL LA) FOR INCONTINENCE. PATIENT WAS ALLERGIC TO EPINEPHRINE (PALPITATIONS). ON (B)(6) 2014 (FIVE WEEKS AGO), THE PATIENT INITIATED TREATMENT WITH SYNVISC INJECTION AT A DOSE OF 02 ML WEEKLY (ROUTE, BATCH/LOT NUMBER AND EXPIRY DATE: UNKNOWN) INTO THE LEFT KNEE FOR DEGENERATIVE KNEE. ON (B)(6) 2014, THE PATIENT RECEIVED THE THIRD INJECTION OF SYNVISC AND THE THERAPY WAS COMPLETED THE SAME DAY. THE PATIENT STATED THAT SHE HAD NO RELIEF FROM PAIN AND DID NOT SEE ANY RESULTS FROM THE SERIES (SUBTHERAPEUTIC RESPONSE). HER KNEE WAS SWELLING, THE PATIENT STATED THAT SINCE SYNVISC TREATMENT HER DOCTOR HAD TAKEN OUT FLUID SEVERAL TIMES FROM HER KNEE. IF SHE WAS ON HER FEET FOR TOO LONG, HER FEET SWELL AND HURT. SHE USED OSMO PATCHES FROM (B)(6), THAT DREW OUT FLUID OUT OF KNEE. SHE USED TO APPLY IT TO HER KNEE AT NIGHT AND IT DREW OUT LIQUID. THE PATIENT STATED THAT HER DOCTOR WAS AWARE OF THIS PATCH. SHE FURTHER STATED THAT CORTISONE SHOTS DID NOT DO ANYTHING FOR HER EITHER. CORRECTIVE TREATMENT: IBUPROFEN AND CORTISONE FOR THE EVENTS OF FEET SWELL AND HURT AND KNEE WAS SWELLING. OUTCOME: UNKNOWN FOR "NOT RELIEF FROM PAIN" AND NOT RECOVERED/NOT RESOLVED FOR FEET SWELL, FEET HURT, KNEE WAS SWELLING, "TAKEN OUT FLUID SEVERAL TIMES FROM HER KNEE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327982 SYNVISC INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention GLIPIZIDE (CON.)| TOLTERODINE L-TARTRATE (CON.)| CORTISONE (CON.)| EPINEPHRINE (PREV.)| ESTRADIOL (CON.)| ARMOUR THYROID (CON.)| LISINOPRIL (CON.)