BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC (SYNVISC)

    MDR report key: 4092187 · Received August 21, 2014

    Report

    Report Number
    2246315-2014-90460
    Event Type
    Injury
    Date Received
    August 21, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 2, 2014
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH (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 WILL CONTINUE TO MONITOR ADVERSE EVENTS TO DETERMINE IF A CAPA WAS REQUIRED. REPORTER CAUSALITY ASSESSMENT: PROBABLE FOR ANAPHYLACTOID REACTION SERIOUSNESS CRITERIA: IMPORTANT MEDICAL EVENT FOR ANAPHYLACTOID REACTION PER NEW IME LIST ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2014. PTC RESULTS WERE ADDED. ADDITIONAL INFORMATION WAS RECEIVED ON 14-AUG-2014 FROM THE ORTHOPAEDIST. THIS CASE INITIALLY CONSIDERED AS NON-SERIOUS WAS UPGRADED TO SERIOUS. THE CASE WAS MEDICALLY CONFIRMED. THE ADDITIONAL EVENTS OF ANAPHYLACTOID REACTION, JOINT PUNCTION OF EFFUSION AND FEELING OF TENSION IN BOTH KNEES AND THEIR DETAILS WERE ADDED. ALSO, THE EVENTS OF SEVERE CHILLS AND DID NOT FEEL WELL WERE UPDATED AS SYMPTOMS OF ANAPHYLACTOID REACTION. THERAPY DATES, ADDITIONAL INDICATION AND ROUTE OF SYNVISC, PATIENT'S AGE, REPORTER CAUSALITY ASSESSMENT, LABORATORY DETAILS AND CORRECTIVE TREATMENT FOR THE EVENT OF KNEES SWOLLEN WERE ADDED. CLINICAL COURSE UPDATED AND TEXT AMENDED ACCORDINGLY.

    Description of Event or Problem · 1

    BASED ON ADDITIONAL INFORMATION RECEIVED ON 14-AUG-2014 FROM THE PHYSICIAN, THIS CASE INITIALLY CONSIDERED AS NON-SERIOUS WAS UPGRADED TO SERIOUS AS THE SERIOUS EVENT OF ANAPHYLACTOID REACTION (IMPORTANT MEDICAL EVENT) WAS ADDED. ALSO, THE CASE WAS MEDICALLY CONFIRMED. THIS UNSOLICITED DEVICE CASE WAS RECEIVED FROM (B)(6) ON (B)(6) 2014 FROM A PATIENT'S WIFE. BASED ON ADDITIONAL INFORMATION RECEIVED ON 14-AUG- 2014, THE ADDITIONAL EVENTS OF ANAPHYLACTOID REACTION, JOINT PUNCTION OF EFFUSION AND FEELING OF TENSION IN BOTH KNEES WERE ADDED. ALSO, THE EVENTS OF SEVERE CHILLS AND DID NOT FEEL WELL WERE UPDATED AS SYMPTOMS OF ANAPHYLACTOID REACTION, THIS CASE INVOLVES A (B)(6) YEARS OLD MALE PATIENT WHO EXPERIENCED ANAPHYLACTOID REACTION, FEELING OF TENSION IN BOTH KNEES, WHOSE KNEES WERE SWOLLEN AND HAD JOINT PUNCTION OF EFFUSION AFTER RECEIVING TREATMENT WITH SYNVISC. NO MEDICAL HISTORY, CONCOMITANTS, PAST DRUGS OR CONCURRENT CONDITIONS WAS REPORTED. ON (B)(6) 2014, THE PATIENT INITIATED TREATMENT WITH INTRA-ARTICULAR SYNVISC INJECTION (DOSAGE REGIMEN, BATCH/LOT NUMBER AND EXPIRY DATE: UNKNOWN) FOR KNEE ARTHROSIS AND VARUS ON ARTHROSIS. ON (B)(6) 2014, PATIENT RECEIVED SECOND SYNVISC INJECTION. THE INJECTIONS HAD BEEN TOLERATED WELL. ON (B)(6) 2014, THE PATIENT RECEIVED THE THIRD APPLICATION OF SYNVISC INJECTION IN BOTH KNEES. THE SAME DAY, DURING NIGHT AFTER THIRD INJECTION, THE PATIENT DEVELOPED ANAPHYLACTOID REACTION, SEVERE CHILLS, MALAISE, PALPATION AND FEELING OF TENSION IN BOTH KNEES. THERE WAS NO FEVER. ON (B)(6) 2014 (16 DAYS AFTER INITIATING TREATMENT WITH SYNVISC), THE PATIENT REPORTED THAT HE DID NOT FEEL WELL AND HIS KNEES WERE SWOLLEN. ON AN UNKNOWN DATE IN 2014, JOINT PUNCTION OF EFFUSION WAS PERFORMED AND 90 ML SEROUS FLUID WAS REMOVED. ON AN UNKNOWN DATE IN 2014, PATIENT RECOVERED FROM THE EVENT OF ANAPHYLACTOID REACTION. ACTION TAKEN: NO ACTION TAKEN CORRECTIVE TREATMENT: NOT REPORTED FOR THE EVENTS OF ANAPHYLACTOID REACTION, FEELING OF TENSION IN BOTH KNEES AND JOINT PUNCTION OF EFFUSION. OUTCOME: RECOVERED/RESOLVED FOR ANAPHYLACTOID REACTION; UNKNOWN FOR KNEES SWOLLEN, FEELING OF TENSION IN BOTH KNEES AND JOINT PUNCTION OF EFFUSION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504662 SYNVISC (SYNVISC) INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD)

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other CON MEDS: UNKNOWN| PREV MEDS: UNKNOWN