BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 3010325 · Received March 14, 2013

    Report

    Report Number
    2246315-2013-00049
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 23, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA (QUALITY ASSURANCE) INVESTIGATION SUMMARY WAS RECEIVED ON (B)(4) 2013. EVALUATION SUMMARY: THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH RECORD REVIEW IS NOT POSSIBLE. 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. DATA IS PERIODICALLY PRESENTED AND REVIEWED BY INDIVIDUALS RESPONSIBLE FOR ASSURING PRODUCT QUALITY. THIS REVIEW HAS NOT INDICATED TRENDS THAT COULD BE ASSOCIATED WITH ANY PRODUCT COMPLAINT. GENZYME WILL CONTINUE TO MONITOR COMPLAINTS. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    COULD NOT PUT WEIGHT ON THAT LEG [WEIGHT BEARING DIFFICULTY], KNEE WAS PAINFUL [ARTHRALGIA], KNEE WAS SWOLLEN [JOINT SWELLING], COULD BARELY WALK [GAIT DISTURBANCE], KNEE EFFUSION [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2013 FROM A CONSUMER (PATIENT'S WIFE) REGARDING A MALE PATIENT, (B)(6). THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PATIENT INITIATED TREATMENT WITH SYNVISC (HYLAN G-F 20) INJECTION (ROUTE AND DOSAGE REGIMEN NOT PROVIDED), INTO AN UNSPECIFIED LOCATION. THE LOT NUMBER FOR SYNVISC WAS NOT PROVIDED. FOLLOWING THE FIRST INJECTION OF SERIES OF 3 INJECTIONS, THE PATIENT DEVELOPED PAIN AND THE PATIENT HAD TO BE TAKEN TO THE HOSPITAL IN AMBULANCE. IT WAS REPORTED THAT THE PATIENT HAD A HORRIBLE REACTION. THE ACTION TAKEN WITH SYNVISC TREATMENT WAS NOT PROVIDED. THE OUTCOME FOR THE EVENT WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT WAS SEVERE. THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT OF PAIN WAS NOT PROVIDED. FOLLOW UP INFORMATION WAS RECEIVED ON (B)(6) 2013 FROM THE PATIENT REGARDING PATIENT INFORMATION, RELEVANT HISTORY, EVENT INFORMATION AND CLINICAL COURSE WHICH UPGRADED THE CASE TO SERIOUS. THE PATIENT'S INITIALS WERE UPDATED TO (B)(6). ON (B)(6) 2013, THE PATIENT INITIATED TREATMENT WITH SYNVISC. ON THE SAME NIGHT, PATIENT'S KNEE WAS PAINFUL (PREVIOUSLY REPORTED AS PAIN), SWOLLEN AND THE PATIENT COULD NOT PUT WEIGHT ON THAT LEG. ON (B)(6) 2013 (THE NEXT MORNING AT 8:00 AM), THE PATIENT WAS TAKEN TO THE HOSPITAL IN AMBULANCE. IT WAS REPORTED THAT THE PATIENT WAS GIVEN A SHOT FOR PAIN. ON (B)(6) 2013, AFTER 3 DAYS, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. IT WAS REPORTED THAT THE PATIENT COULD BARELY WALK. ON (B)(6) 2013, THE PATIENT'S KNEE WAS SO BAD THAT AN UNKNOWN AMOUNT OF FLUID WAS ASPIRATED WHICH RELIEVED THE PAIN. THE PATIENT WAS TREATED WITH TYLENOL-3 (PARACETAMOL) FOR PAIN. IT WAS REPORTED THAT THE PATIENT TOOK SUPPOSITORIES, PRUNES AND JUICES FOR THE CONSTIPATION CAUSED BY TYLENOL-3. THE PATIENT WAS IN UNRELENTING PAIN, SUFFERING, ANGUISH AND DISABILITY. THE EVENTS OF KNEE WAS PAINFUL AND COULD BARELY WALK WERE NOT YET RECOVERED AND THE OUTCOME FOR THE EVENTS OF KNEE WAS SWOLLEN, KNEE EFFUSION AND COULD NOT PUT WEIGHT ON THAT LEG WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENTS OF KNEE WAS SWOLLEN, KNEE EFFUSION, COULD NOT PUT WEIGHT ON THAT LEG AND COULD BARELY WALK WAS NOT PROVIDED. . THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENTS OF KNEE WAS SWOLLEN, KNEE EFFUSION, COULD NOT PUT WEIGHT ON THAT LEG AND BARELY WALK WAS NOT PROVIDED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108378 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization