BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 3242901 · Received July 19, 2013

    Report

    Report Number
    2246315-2013-00406
    Event Type
    Injury
    Date Received
    July 19, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 19, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    PMA P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP INFORMATION WAS RECEIVED ON (B)(4) 2013 IN THE FORM OF QA (QUALITY ASSURANCE) INVESTIGATION RESULTS. 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 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 CORRECTIVE ACTION IS REQUIRED. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP BETWEEN SYNVISC ONE AND ALL THE EVENTS AS DEFINITE.

    Description of Event or Problem · 1

    ALLERGIC REACTION [HYPERSENSITIVITY], RIGHT KNEE SWELLING [JOINT SWELLING], RIGHT KNEE EFFUSION [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A (B)(6) FEMALE PATIENT, INITIALS (B)(6) WITH PATELLAR CHONDROMALACIA AND CARTILAGE WEAR (WEAR KNEE). THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. ON (B)(6) 2013 AT 11:00 AM, THE PATIENT INITIATED TREATMENT WITH A SINGLE SYNVISC ONE (HYLAN GF 20) INJECTION, DOSAGE REGIMEN AND ROUTE OF ADMINISTRATION NOT PROVIDED. THE LOT NUMBER FOR SYNVISC-ONE WAS NOT PROVIDED. ON (B)(6) 2013, THE FOLLOWING DAY AFTER SYNVISC-ONE INJECTION, THE PATIENT PRESENTED WITH KNEE SWELLING AND REPORTED THE EVENT TERMS AS 'REJECTION REACTION', 'ALLERGIC REACTION' AND 'SWOLLEN BALL'. ON AN UNSPECIFIED DATE IN (B)(6) 2013, THE PATIENT UNDERWENT 02 PUNCTURES TO REMOVE THE LIQUID AND WAS TREATED WITH ANTI-INFLAMMATORY DRUGS. IT WAS REPORTED THAT THE KNEE SWELLING HAD IMPROVED BUT THE 'KNEE WAS STILL SWOLLEN'. THE PATIENT HAD NOT YET RECOVERED FROM THE EVENT OF ALLERGIC REACTION AND THE OUTCOME FOR THE EVENT JOINT EFFUSION WAS NOT PROVIDED. IT WAS REPORTED THAT THE PATIENT WAS NOT ON ANY CONCOMITANT MEDICATIONS. THE INTENSITY FOR ALL THE EVENTS WAS NOT PROVIDED. THE RELATIONSHIP BETWEEN SYNVISC ONE AND ALL THE EVENTS WAS NOT PROVIDED BY THE REPORTER. FOLLOW UP INFORMATION WAS RECEIVED ON (B)(6) 2013 FROM THE PHYSICIAN REGARDING THE PATIENT'S MEDICAL HISTORY, SUSPECT THERAPY DETAILS AND EVENTS INFORMATION. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR PREVIOUS TREATMENT WITH NSAID (NON-STEROIDAL ANTI-INFLAMMATORY DRUG), VISCOSUPPLEMENTATION WITH SYNVISC AND MODERATE OSTEOARTHRITIS (WITH JOINT NARROWING AND OSTEOPHYTES). IT WAS REPORTED THAT THE PATIENT RECEIVED TREATMENT WITH INTRA-ARTICULAR SYNVISC ONE INJECTION, AT A DOSE OF 6 ML, IN RIGHT KNEE. ON AN UNSPECIFIED DATE, THE PATIENT WAS HOSPITALIZED FOR THE EVENTS OF ALLERGIC REACTION, RIGHT KNEE SWELLING AND RIGHT KNEE EFFUSION. ON AN UNSPECIFIED DATE, THE PATIENT WAS HOSPITALIZED FOR THE EVENTS OF ALLERGIC REACTION, RIGHT KNEE SWELLING AND RIGHT KNEE EFFUSION. ON AN UNSPECIFIED DATE IN (B)(6) 2013, 10 ML FLUID WAS ASPIRATED AFTER TREATMENT WITH SYNVISC ONE FROM RIGHT KNEE. IN ADDITION, THE PATIENT RECEIVED TREATMENT WITH ANALGESICS AND NSAID FOR THE EVENT OF ALLERGIC REACTION. ON UNSPECIFIED DATES, THE PATIENT RECOVERED FROM THE EVENTS OF ALLERGIC REACTION, RIGHT KNEE SWELLING AND RIGHT KNEE EFFUSION. THE INTENSITY FOR ALL THE EVENTS WAS SEVERE. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC ONE AND ALL THE EVENTS AS DEFINITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338268 SYNVISC ONE (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization