BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC ONE (SYNVISC ONE)

    MDR report key: 4152407 · Received August 4, 2014

    Report

    Report Number
    2246315-2014-01810
    Event Type
    Injury
    Date Received
    August 4, 2014
    Date of Event
    July 26, 2014
    Report Date
    July 28, 2014
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS UNSOLICITED DEVICE CASE FROM (B)(6) WAS RECEIVED ON (B)(6) 2014 FROM A NURSE. THIS CASE CONCERNS AN (B)(6) YEAR OLD FEMALE PATIENT WHO EXPERIENCED SUSPECTED ALLERGIC REACTION TO SYNVISC ONE AFTER RECEIVING TREATMENT WITH SYNVISC -ONE AND HAD SYNVISC ONE ASPIRATED. NO PAST DRUGS, MEDICAL HISTORY, CONCOMITANT MEDICATIONS OR CONCURRENT CONDITION WAS REPORTED. ON (B)(6) 2014, THE PATIENT RECEIVED TREATMENT WITH SYNVISC ONE INJECTION (ROUTE, DOSE, FREQUENCY, BATCH/LOT NUMBER AND EXPIRATION DATE: UNK) INTO LEFT KNEE FOR AN UNKNOWN INDICATION. THE SAME DAY, THE PATIENT EXPERIENCED SWELLING AND REDNESS AT HER KNEE, THIGH AND CALF TWO HOURS AFTER RECEIVING SYNVISC ONE INJECTION. IT WAS REPORTED THAT THE PATIENT FELT BETTER AFTER TAKING NSAID AS ADVISED BY HER DOCTOR. ON (B)(6) 2014, THE PATIENT'S SITUATION GOT WORSE AGAIN AND THE SAME DAY SHE WAS ADMITTED TO THE HOSPITAL WHERE THE INJECTED SYNVISC ONE WAS ASPIRATED. FURTHER REPORTED, THE SITUATION OF THE PATIENT WAS STABLE. THE REPORTER SUSPECTED THE PATIENT WAS ALLERGIC TO SYNVISC ONE. ACTION TAKEN: UNK. CORRECTIVE TREATMENT: NOT REPORTED. OUTCOME: UNKNOWN FOR BOTH THE EVENTS. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED AND PTC RESULTS WERE PENDING FOR THE SAME. NO FURTHER INFORMATION WAS AVAILABLE AT THE MOMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453848 SYNVISC ONE (SYNVISC ONE) INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization PREV MEDS = UNK| CON MEDS = UNK