BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2519802 · Received March 28, 2012

    Report

    Report Number
    2246315-2012-00081
    Event Type
    Other
    Date Received
    March 28, 2012
    Date of Event
    February 16, 2012
    Report Date
    February 23, 2012
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S COMMENT: AS ONLY LIMITED INFO HAS BEEN OBTAINED SO FAR, IT IS DIFFICULT TO ASSESS A CAUSE AND EFFECT RELATIONSHIP.

    Description of Event or Problem · 1

    ADVERSE REACTION (BOTH KNEES) [ADVERSE REACTION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2012 FROM A PHYSICIAN REGARDING A PT, UNK INITIALS. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PT INITIATED TREATMENT WITH SYNVISC-ONE (HYLAN G-F20) AT A DOSE OF 6 ML ONCE, IN AN UNSPECIFIED LOCATION. THE LOT NUMBER OF SYNVISC-ONE WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PT EXPERIENCED AN ADVERSE REACTION. THE ACTION TAKEN WITH SYNVISC-ONE TREATMENT WAS UNK. THE OUTCOME FOR THE EVENT OF "ADVERSE REACTION" WAS NOT PROVIDED. RELEVANT CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY OF THE EVENT OF "ADVERSE REACTION" WAS NOT PROVIDED. THE REPORTING PHYSICIAN DID NOT PROVIDE THE RELATIONSHIP BETWEEN SYNVISC-ONE AND THE EVENT OF "ADVERSE REACTION". ADD'L INFO WAS RECEIVED ON 03/04/2012 FROM THE PHYSICIAN. IT WAS CONFIRMED THAT THE PT WAS ADMINISTERED SYNVISC INSTEAD OF SYNVISC-ONE. THE PT HAD THREE INJECTIONS. ADD'L INFO WAS RECEIVED ON 03/19/2012 FROM THE PHYSICIAN WHICH UPGRADED THE CASE FROM NON-SERIOUS TO SERIOUS. THE PT WAS A (B)(6) FEMALE PT WITH INITIALS (B)(6). THE PT'S MEDICAL HISTORY WAS SIGNIFICANT FOR OSTEOARTHRITIS (GRADE: SEVERE, X-RAY GRADE: IV, DURATION: YEARS BY HISTORY, PRIOR EFFUSION, JOINT NARROWING AND OSTEOPHYTES PRESENT) AND VISCO SUPPLEMENTATION WITH AN UNK PRODUCT. ON (B)(6) 2012, THE PT INITIATED TREATMENT WITH SYNVISC (HYLAN G-F20) AT A DOSE OF 2ML, 1X/W, IN BOTH THE KNEES. THE LOT NUMBER OF SYNVISC WAS NOT PROVIDED. ON (B)(6) 2012, THE PT RECEIVED SECOND INJECTION OF SYNVISC. ON (B)(6) 2012, AFTER RECEIVING THIRD INJECTION OF SYNVISC, THE PT EXPERIENCED AN ADVERSE REACTION IN BOTH THE KNEES. ON AN UNSPECIFIED DATE THE PT INITIATED TREATMENT WITH ICE, ACTIVITY MODIFICATIONS, MEDROL (METHYLPREDNISOLONE) (DOSE PACK). THE ACTION TAKEN WITH SYNVISC TREATMENT WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PT RECOVERED WITH SEQUELAE FROM THE ADVERSE REACTION. RELEVANT CONCOMITANT MEDICATIONS REPORTED INCLUDE ATENOLOL, DOXAZOSIN, BENAZEPRIL, ROPINIROLE, SIMVASTATIN, OXYBIOTIN (OXYBUTYNIN HYDROCHLORIDE) AND ASPIRIN (ACETYLSALICYLIC ACID). THE INTENSITY FOR THE ADVERSE REACTION WAS ASSESSED AS SEVERE. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND THE ADVERSE REACTION AS POSSIBLE.

    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 74 YR Required Intervention BENAZEPRIL (BENAZEPRIL) UNK TO UNK| ASPIRIN (ACETYLSALICYLIC ACID) UNK TO UNK| ROPINIROLE (ROPINIROLE) UNK TO UNK| OXYBUTIN (OXYBUTYNIN HYDROCHLORIDE) UNK TO UNK| DOXAZOSIN (DOXAZOSIN) UNK TO UNK| ATENOLOL (ATENOLOL) UNK TO UNK| SIMVASTATIN (SIMVASTATIN) UNK TO UNK