BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 4142556 · Received October 1, 2014

    Report

    Report Number
    2246315-2014-10934
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    November 1, 2012
    Report Date
    August 14, 2014
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICATIONS INCLUDED WARFARIN, RIVAROXABAN (XARELTO) AS BLOOD THINNER, METOPROLOL TARTRATE (METOPROLOL) FOR HIGH BLOOD PRESSURE, FUROSEMIDE FOR EDEMA/ DIURETIC FLUID AND ALLOPURINOL FOR GOUT. IT WAS REPORTED THAT THE PATIENT WAS ALLERGIC TO COMBINATION OF PERCOSET AND MORPHINE WHICH RESULTED IN NAUSEA. ON AN UNKNOWN DATE (B)(6) 2012, (AT ABOUT 13:00-13:30 HOURS), THE PATIENT INITIATED TREATMENT WITH SYNVISC INJECTION AT A DOSE OF 02 ML ONCE (ROUTE OF ADMINISTRATION, BATCH/LOT NUMBER AND EXPIRY DATE: UNKNOWN) INTO AN UNSPECIFIED LOCATION FOR OSTEOARTHRITIS (BONE ON BONE). THE PATIENT HAD A BAD REACTION AFTER THE FIRST SHOT. WITHIN ONE HOUR, KNEE/ CALF BLEW UP ALONG WITH MASSIVE SWELLING (SWELLING). THE PATIENT REPORTED THAT AFTER SHE GOT HOME SHE WENT TO SIT DOWN ON TOILET AND FELT STRANGE AS IF SOMETHING POP IN HER LEG TWO TIMES/ LEG POP LIKE BUBBLE AND THIS HAPPENED TWO TIMES. THE PATIENT WONDERED IF THE HEALTHCARE PROFESSIONAL INJECTED IN THE WRONG SPOT. ON THE FOLLOWING DAY, AT 06: 00 HOURS, THE LEG OF THE PATIENT WAS PURPLE FOR DAYS, BLISTER FORMED ON HER CALF WITH MASSIVE PAIN DUE TO WHICH SHE COULDN'T MOVE; THEREFORE, SHE NEEDED BED PAN FOR SEVERAL DAYS. IT WAS REPORTED THAT THE PATIENT NEVER WENT BACK FOR THE OTHER TWO INJECTIONS. ON AN UNKNOWN DATE IN (B)(6) 2012, THE PATIENT WAS UNABLE TO WALK; THEREFORE, SHE CALLED AMBULANCE TO VISIT EMERGENCY ROOM WHERE SHE WAS TREATED WITH PAIN KILLER AND ANTIBIOTICS (BOTH UNSPECIFIED) AND RELEASED. ON AN UNKNOWN DATE IN (B)(6) 2012, THE PATIENT DEVELOPED CELLULITIS (SKIN INFECTION) ALONG WITH BROWN COLORED LARGE SCAR AND SHE EVENTUALLY HAD A HOLE OF 3 INCH IN DIAMETER IN HER LEG. ON (B)(6) 2013 (FIVE MONTHS AFTER SYNVISC), THE PATIENT WAS ADMITTED AND ON AN UNKNOWN DATE IN 2013, PATIENT'S BLOOD TEST WAS PERFORMED WHICH SHOWED GOUT IN HANDS AND INFECTION IN LEG. ALSO REPORTED THAT MAGNETIC RESONANCE IMAGING (MRI) WAS SUGGESTED, BUT THE PATIENT WAS AFRAID OF INFRARED RAYS ON OPEN WOUND. THE BLISTERS TURNED INTO A .02 INCH HOLE IN HER LEG WHICH TOOK 11 MONTHS TO HEAL. A HOME NURSE CARE VISITED TO PACK (CONSISTED OF SALT) AS HEAL CHANGE THE BANDAGE FOR DRAINAGE WHICH TOOK 10-11 MONTHS TO HEAL. LATER, ON AN UNKNOWN DATE IN 2013 (B)(6), THE WOUND CARE ENDED DUE TO INSURANCE AND PATIENT WAS ABLE TO SELF-CARE. AS PER THE REPORTER, BEING ON BLOOD THINNER, SHE SHOULD HAD BEEN INFORMED TO GET OFF THE MEDICATION BEFORE ADMINISTRATION OF SYNVISC SHOT, AS THE PUNCTURE CAUSED BLOOD TO POOL IN LARGE AREA. ALSO, THE PATIENT WAS CONSIDERING CONSULTING A LAWYER REGARDING THE PAIN AND SUFFERING FROM THE SYNVISC SHOT (NEGLIGENCE TO STOP BLOOD THINNER FOR PROCEDURE). ON AN UNKNOWN DATE IN (B)(6) 2014, THE PATIENT ADMITTED FOR GOUT AND LEG WOUND. ACTION TAKEN: WITHDRAWN NOS (NOT OTHERWISE SPECIFIED) OUTCOME: RECOVERED/ RESOLVED FOR THE EVENTS OF CELLULITIS, UNABLE TO WALK, WITHIN 1 HOUR KNEE/ CALF BLEW UP/MASSIVE SWELLING AND EVENTUALLY HAD A HOLE IN HER LEG. UNKNOWN FOR THE EVENT OF FELT SOMETHING POP IN HER LEG TWO TIMES/ LEG POP LIKE BUBBLE, COULDN'T MOVE BECAUSE OF PAIN, COULDN'T MOVE BECAUSE OF PAIN/ MASSIVE PAIN, HER LEG WAS PURPLE FOR DAYS, BLISTER FORMED ON HER CALF AND BAD REACTION AFTER FIRST SHOT. A PHARMACEUTICAL COMPLAINT (PTC) WAS INITIATED WITH GLOBAL PTC NUMBER: (B)(4). THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH RECORD REVIEW IS NOT POSSIBLE. BASED ON THE LACK OF INFORMATION PROVIDED, NO CAPA IS REQUIRED. IT IS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR SPECIFICATION CONFORMANCE PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT IS IDENTIFIED AND MITIGATED THROUGH THE NCR PROCESS. DATA IS PERIODICALLY PRESENTED AND REVIEWED BY INDIVIDUALS RESPONSIBLE FOR ASSURING PRODUCT SAFETY. THIS REVIEW HAS NOT INDICATED ANY SAFETY ISSUE. GENZYME BIOSURGERY WILL CONTINUE TO MONITOR ADVERSE EVENTS TO DETERMINE IF A CAPA IS REQUIRED. SERIOUSNESS CRITERIA: IMPORTANT MEDICAL EVENT FOR THE EVENT OF CELLULITIS AND HOSPITALIZATION FOR THE EVENT OF EVENTUALLY HAD A HOLE IN HER LEG ADDITIONAL INFORMATION WAS RECEIVED ON 22-SEP-2014 FROM PATIENT. PATIENT'S HEIGHT WAS UPDATED. HISTORICAL CONDITIONS, ALLERGIC DRUGS, CONCOMITANT MEDICATIONS, CONCURRENT CONDITIONS AND LABORATORY DATA WERE ADDED. START DATE AND STOP DATE OF SUSPECT DRUG WAS UPDATED TO (B)(6) 2012 FROM UNKNOWN. ADDITIONAL EVENTS OF CELLULITIS, UNABLE TO WALK, WITHIN 1 HOUR KNEE/ CALF BLEW UP/ MASSIVE SWELLING ALONG WITH ITS DETAILS WAS ADDED. ALSO, THE REPORTED TERM FOR THE EVENTS WAS UPDATED FROM "FELT SOMETHING POP IN HER LEG TWO TIMES" TO "FELT SOMETHING POP IN HER LEG TWO TIMES/ LEG POP LIKE BUBBLE", FROM "COULDN'T MOVE BECAUSE OF PAIN" TO "COULDN'T MOVE BECAUSE OF PAIN/ MASSIVE PAIN". CLINICAL COURSE WAS UPDATED AND TEXT WAS AMENDED ACCORDINGLY. PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT DATED (B)(4) 2014: IN THIS CASE THE CAUSAL ROLE OF THE SUSPECT SYNVISC CANNOT BE EXCLUDED FOR THE OCCURENCE OF THE EVENT OF CELLULITIS, WOUND NOS, HOWEVER, THE LACK OF INFORMATION REGARDING THE CONCOMITANT MEDICATIONS USED BY THE PATIENT, UNDERLYING MEDICAL HISTORY PRECLUDES THE COMPLETE CASE ASSESSMENT.

    Description of Event or Problem · 1

    BASED ON ADDITIONAL INFORMATION RECEIVED ON 22-SEPTEMBER-2014, THIS CASE INITIALLY CONSIDERED AS NON-SERIOUS WAS UPGRADED TO SERIOUS AS THE SERIOUS EVENTS OF "CELLULITIS" AND "EVENTUALLY HAD A HOLE IN HER LEG" WITH SERIOUSNESS CRITERIA OF IMPORTANT MEDICAL EVENT AND HOSPITALIZATION RESPECTIVELY WERE ADDED. THIS UNSOLICITED DEVICE CASE WAS RECEIVED FROM UNITED STATES ON (B)(6) 2014 FROM A CONSUMER. ADDITIONAL INFORMATION WAS RECEIVED ON 18-AUGUST-2014. BOTH THE INFORMATION WAS PROCESSED TOGETHER WITH CLOCK START DATE TICK FOR (B)(6) 2014. THIS CASE INVOLVES A (B)(6) FEMALE PATIENT WHO DEVELOPED CELLULITIS, EVENTUALLY HAD A HOLE IN HER LEG (WOUND NOS), FELT SOMETHING POP IN HER LEG TWO TIMES/LEG POP LIKE BUBBLE, COULDN'T MOVE BECAUSE OF PAIN (MOVEMENTS REDUCED), COULDN'T MOVE BECAUSE OF PAIN/ MASSIVE PAIN (PAIN), HER LEG WAS PURPLE FOR DAYS (DISCOLORATION SKIN), BLISTER FORMED ON HER CALF, WAS UNABLE TO WALK, WITHIN 1 HOUR KNEE/CALF BLEW UP/MASSIVE SWELLING (SWELLING) AND HAD BAD REACTIONS AFTER FIRST SHOT (UNEVALUABLE EVENT) AFTER RECEIVING TREATMENT WITH SYNVISC INJECTION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED CHRONIC HEART FAILURE. PAST DRUG INCLUDED WARFARIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611499 SYNVISC INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| O FUROSEMIDE| WARFARIN| OXYCODONE| ALLOPURINOL| XARELTO| METOPROLOL| MORPHINE| WARFARIN