BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 1960203 · Received January 3, 2011

    Report

    Report Number
    2246315-2011-00001
    Event Type
    Other
    Date Received
    January 3, 2011
    Date of Event
    November 1, 2010
    Report Date
    December 23, 2010
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ITCHY RASH (HIVES) ON FOREARMS, BACK STOMACH, UPPER HIPS, GROIN AND ANKLE [URTICARIA]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6)-2010 FROM A (B)(6) MALE PT, INITIALS (B)(6), WITH A HISTORY OF OSTEOARTHRITIS AND PREVIOUS SYNVISC TREATMENT ((B)(6)-2009), WHO EXPERIENCED GENERALIZED URTICARIA AFTER STARTING SYNVISC-ONE. THE PT RECEIVED A SYNVISC-ONE INJECTION INTO HER RIGHT KNEE ON (B)(6)-2010. THE PT REPORTED THAT THREE MONTHS AFTER RECEIVING THE INJECTION HE DEVELOPED "AN ITCHY RASH" THAT STARTED ON HIS FOREARMS AND SPREAD TO HIS BACK, STOMACH, UPPER HIPS, GROIN AND ANKLE (DATE NOT PROVIDED). THE PT REPORTED THAT HIS SYMPTOMS WERE TREATED WITH A TOPICAL STEROID CREAM AS WELL AS PREDNISONE ((B)(6)-2010). THE PRODUCT LOT NUMBER WAS NOT PROVIDED. AT THE TIME OF THIS REPORT THE OUTCOME OF THE PT WAS NOT YET RECOVERED. ADDITIONAL INFO WAS RECEIVED ON (B)(6)-2010 FROM A HEALTHCARE PROFESSIONAL. THE HCP CONFIRMED THAT THE PT RECEIVED THE SYNVISC-ONE INJECTION IN (B)(6)-2010. THE HCP, A DERMATOLOGIST, REPORTED THAT SHE SAW THE PT FOR FIRST TIME IN (B)(6)-2010 AND THAT HE PRESENTED WITH GENERALIZED URTICARIA, WHICH STARTED ON HIS ELBOWS AND ANKLES AND SPREAD TO HIS ARMS, LEGS, TRUNK AND NECK. THE PT REQUIRED TREATMENT FOR HIS SYMPTOMS. THE HCP REPORTED THE PT WAS TREATED WITH MISCELLANEOUS UNK TOPICAL MEDICATIONS AS WELL AS ORAL BENADRYL. THE HCP ALSO REPORTED THAT SHE PRESCRIBED PREDNISONE ORAL TO THE PT IN (B)(6)-2010. THE HCP STATED THAT THE RELATIONSHIP OF THE EVENT TO THE SYNVISC-ONE TREATMENT WAS PROBABLE. THE PRODUCT LOT NUMBER WAS NOT PROVIDED. AT THE TIME OF THIS REPORT THE OUTCOME OF THE PT WAS NOT YET RECOVERED. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention