BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2170108 · Received June 21, 2011

    Report

    Report Number
    2246315-2011-00145
    Event Type
    Other
    Date Received
    June 21, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 15, 2011
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    EXANTHEMA GENERALISED [RASH GENERALISED]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2011 FROM A PHYSICIAN, REGARDING A (B)(6), MALE, PT, INITIALS (B)(6). THE PT'S MEDICAL HISTORY IS SIGNIFICANT FOR GONARTHROSIS. ON (B)(6) 2011, THE PT INITIATED THE FIRST SYNVISC INJECTION OF 2 ML INTO THE LEFT KNEE. THE SYNVISC LOT NUMBER WAS NOT PROVIDED. ON (B)(6) 2011, THE PT INITIATED THE SECOND SYNVISC INJECTION OF 2 ML INTO THE LEFT KNEE AND FIRST SYNVISC INJECTION OF 2 ML INTO THE RIGHT KNEE. ON (B)(6) 2011, THE PT DEVELOPED EXANTHEMA GENERALIZED. ON (B)(6) 2011, THE PT VISITED THE HOSPITAL (SURGERY DEPARTMENT). DURING THE VISIT, THE PT WAS TREATED WITH INJECTIONS; GLYCYRRHIZIN GLYCINE CYSTEINE COMBINED DRUG AND 5 MG OF CHLORPHENIRAMINE MALEATE AND WAS PRESCRIBED ORAL MEDICATION; OLOPATADINE HYDROCHLORIDE, FROM (B)(6) 2011 UNTIL (B)(6) 2011. THE PT DID NOT RECEIVE ANY FURTHER SYNVISC INJECTIONS. ON (B)(6) 2011, SYNVISC WAS PERMANENTLY DISCONTINUED. THE PT'S OUTCOME FOR THE EVENT OF EXANTHEMA GENERALIZED WAS REPORTED AS NOT YET RECOVERED. ON (B)(6) 2011, RELEVANT CONCOMITANT MEDICATIONS WERE STARTED. THESE INCLUDED: 100 MG OF CELECOXIB 2/1 DAY; 2MG OF IRSOGLADINE MALEATE 2/1 DAY; 500 MG OF MECOBALAMIN 3/1 DAY AND 5MG OF LIMAPROST ALFADEX 3/1 DAY. THE INTENSITY FOR THE EVENT OF EXANTHEMA GENERALIZED WAS NOT PROVIDED. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT OF EXANTHEMA AS DEFINITELY RELATED.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention CELECOXIB (CELECOXIB) UNK| IRSOGLADINE MALEATE (IRSOGLADINE MALEATE) UNK| LIMAPROST ALFADEX UNK| MECOBALAMIN (MECOBALAMIN) UNK