BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2011828 · Received February 25, 2011

    Report

    Report Number
    2246315-2011-00032
    Event Type
    Other
    Date Received
    February 25, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 15, 2011
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THE REPORT. 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.

    Description of Event or Problem · 1

    DIFFICULTY FOCUSING AND BLURRED VISION [VISION BLURRED]; FATIGUE [FATIGUE]; FEELING DRUNK [FEELING DRUNK]; UNABLE TO STAND UP [DYSSTASIA]; TACHYCARDIA [TACHYCARDIA]; DIZZINESS [DIZZINESS]. ALL THREE INJECTIONS GIVEN INTO EACH KNEE AT THE SAME TIME [DEVICE MISUSE]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2011 FROM A PHYSICIAN REGARDING A (B)(6) FEMALE PT, INITIALS (B)(6), WITH A HISTORY OF OSTEOARTHRITIS, WHO EXPERIENCED DEVICE MISUSE, TACHYCARDIA, DIZZINESS, FATIGUE AND BLURRED VISION AFTER STARTING SYNVISC. THE PHYSICIAN REPORTED THAT THE PT RECEIVED ALL THREE INJECTIONS OF SYNVISC INTO EACH KNEE AT THE SAME TIME ((B)(6) 2011). THE PHYSICIAN REPORTED THAT TWO HOURS AFTER RECEIVING THE INJECTIONS, THE PT EXPERIENCED TACHYCARDIA, DILATED PUPILS AND DIZZINESS. THE NEXT DAY THE HEART RATE DECREASED, BUT THE DIZZINESS PERSISTED (UNABLE TO STAND UP). THE PHYSICIAN REPORTED THE PT COMPLAINED OF "FEELING DRUNK," WITH FEELINGS OF FATIGUE, DIFFICULTY FOCUSING AND BLURRY VISION. THE PT REQUIRED TREATMENT FOR HER SYMPTOMS. THE PHYSICIAN REPORTED THAT THE PT WAS TREATED WITH MECLIZINE AND ON (B)(6) 2011 WAS ADMINISTERED 2 LITERS OF INTRAVENOUS NORMAL SALINE WITHOUT MUCH RESPONSE. THE PHYSICIAN REPORTED THAT THE PT HAD AN UNREMARKABLE HEALTH HISTORY. THE PHYSICIAN ALSO REPORTED THAT THE PT WAS TAKING THE FOLLOWING CONCOMITANT MEDICATIONS: CONCERTA; ORTHO TRICYCLEN. THE SYNVISC LOT NUMBER WAS NOT PROVIDED. THE PHYSICIAN ASSESSED THE EVENTS AS DEFINITELY RELATED TO SYNVISC. AT THE TIME OF THIS REPORT THE OUTCOME OF THE PT WAS NOT YET RECOVERED. ADDITIONAL INFO WAS RECEIVED ON (B)(6) 2011 IN THE FORM OF QA RESULTS. 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.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention ORTHO TRI-CYCLEN (ETHINYLESTRADIOL, NORGESTIMATE)| CONCERTA (METHYLPHENIDATE HYDROCHLORIDE)