BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1047840 · Received May 9, 2008

    Report

    Report Number
    2246315-2008-00069
    Event Type
    Other
    Date Received
    May 9, 2008
    Date of Event
    April 28, 2008
    Report Date
    April 30, 2008
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT LOT NUMBER WAS NOT PROVIDED AND BATCH RECORD REVIEW IS NOT POSSIBLE. IT IS THE REQUIREMENT TO REVIEW ALL FINISH BATCH RECORDS FOR CONFORMANCE TO SPECIFICATIONS PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULTS IS IDENTIFIED AND MITIGATED. ON A PERIODIC BASIS, DATA IS PRESENTED AND REVIEWED BY INDIVIDUALS RESPONSIBLE FOR ASSURING PRODUCT QUALITY. THIS REVIEW HAD NOT INDICATED TRENDS THAT COULD BE ASSOCIATED WITH ANY PRODUCT COMPLAINT. GENZYME WILL CONTINUE TO MONITOR COMPLAINTS.

    Description of Event or Problem · 1

    CHILLS [CHILLS], FLUSHING [FLUSHING], NAUSEA [NAUSEA], FEVER [PYREXIA], DIZZINESS [DIZZINESS], PARESTHESIA [PARAESTHESIA], INCREASED BLOOD PRESSURE [BLOOD PRESSURE INCREASED], WHEEZE [WHEEZING], PAIN IN THE RIGHT KNEE [ARTHRALGIA], SWELLING IN THE RIGHT KNEE [JOINT SWELLING]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON 30-APR-2008 FROM A CONSUMER REGARDING A (B) (6) FEMALE PATIENT, (B) (6). THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED OSTEOARTHRITIS AND PSORIATIC ARTHRITIS. THE PATIENT RECEIVED AN INJECTION OF SYNVISC IN HER RIGHT KNEE ON (B) (6) 2008. LATER THAT EVENING SHE EXPERIENCED PAIN AND SWELLING IN HER RIGHT KNEE. THE PATIENT PROCEEDED TO TAKE LORTAB SHE HAD BEEN PRESCRIBED FOR PAIN. LATER THAT SAME NIGHT, SHE BEGAN TO GRADUALLY EXPERIENCED CHILLS, FLUSHING, NAUSEA, FEVER, DIZZINESS, AND INCREASED BLOOD PRESSURE. THE PATIENT HAD A HISTORY OF HIGH BLOOD PRESSURE WHICH WAS NORMALLY CONTROLLED WITH MEDICATION. THE PATIENT'S BLOOD PRESSURE CONTINUED TO ELEVATE DURING THE NIGHT OF (B) (6) 2008 AND PEAKED AT READINGS OF 210/115 AND 249/149. THE PATIENT WENT TO THE EMERGENCY ROOM. AT THE EMERGENCY ROOM, THE PATIENT HAD AN EKG PERFORMED WHICH CAME BACK NORMAL. THE PATIENT ALSO RECEIVED AN INJECTION OF PHENERGAN. WHILE IN THE EMERGENCY ROOM, THE PATIENT'S BLOOD PRESSURE GRADUALLY RETURNED TO NORMAL WITHOUT ANY SPECIFIC MEDICAL INTERVENTION. IT WAS NOT DETERMINED IF THE PATIENT'S EVENTS WERE RELATED TO SYNVISC, LORTAB, OR SOME OTHER SOURCE AND SHE WAS SENT HOME. THE PATIENT'S KNEE PAIN HAS IMPROVED AND SHE STAYED OFF OF HER FEET AS MUCH AS POSSIBLE. AT THE TIME OF THIS REPORT, THE PATIENT STILL FELT SOME CHILLS, FLUSHING, AND NAUSEA. ON (B) (6) 2008, THE PATIENT STARTED TO WHEEZE FOR THE FIRST TIME. AS OF THE DATE OF RECEIPT OF THIS REPORT, THE PATIENT HAD NOT YET RECOVERED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention