BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 3466886 · Received November 5, 2013

    Report

    Report Number
    2246315-2013-12460
    Event Type
    Injury
    Date Received
    November 5, 2013
    Report Date
    October 31, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED AND THE CONCLUSION WAS PENDING FOR THE SAME. PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT DATED (B)(4) 2013: IN THIS CASE, PT EXPERIENCED "BRIGHT RED BLOOD URINATE/PISSING PURE BLOOD" AFTER RECEIVING TREATMENT WITH SYNVISC. ALTHOUGH, THE ROLE OF DEVICE CANNOT BE RULED OUT BASED ON TEMPORAL AND ANATOMICAL PROXIMITY; HOWEVER, INFORMATION REGARDING CONCOMITANT MEDICATION, PT'S HISTORY OF ALLERGIES TO DRUGS IS REQUESTED FOR BETTER ASSESSEMENT.

    Description of Event or Problem · 1

    THIS SERIOUS UNSOLICITED DEVICE CASE RECEIVED FROM UNITED STATES ON (B)(6) 2013 FROM A PT. (B)(4). THE CASE CONCERNS A (B)(6) MALE PT, WHO URINATED BRIGHT RED BLOOD ("(B)(6) PURE BLOOD, NO DROPS") AND WAS ILL (SICKNESS) WHILST RECEIVING TREATMENT WITH SYNVISC WHICH WAS VERY PAINFUL (PAIN DURING INJECTION). PAST MEDICAL HISTORY INCLUDED MANY ACCIDENTS (HE WAS (B)(6) RACE CAR DRIVER) WITH BROKEN BODY PARTS AND BURNS (SOME VERY SEVERE). THE PT CONCOMITANTLY HAD CHRONIC PAIN. PAST DRUGS AND RELEVANT CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNK DATE (ABOUT 1-2 YEARS AGO), THE PT INITIATED TREATMENT WITH SYNVISC INJECTION, ONCE A WEEK, (DOSE, ROUTE OF ADMINISTRATION, BATCH/LOT NUMBER AND EXPIRY DATE: UNK) INTO AN UNSPECIFIED KNEE FOR AN UNK INDICATION. THE DOCTOR USED "16 GAUGE 6.5 NEEDLE" FOR THE FIRST INJECTION, WHICH WAS VERY PAINFUL (PAIN DURING INJECTION) BUT DID NOT BOTHER HIM. LATER (AFTER ONE WEEK) ON AN UNK DATE, PT RECEIVED SECOND INJECTION OF SYNVISC THAT MADE HIM ILL (SICKNESS). ON AN UNK DATE, THE PT RECEIVED THIRD INJECTION OF SYNVISC, (THOUGH THE PT DID NOT WANT IT BUT DOCTOR INSISTED AND GAVE IT TO HIM) AND TWO HOURS AFTER THIRD INJECTION, PT WAS "(B)(6) PURE BLOOD, NOT DROPS/ URINATED BRIGHT RED BLOOD" (HEMATURIA) WHICH LASTED FOR 24 HOURS. THE PT WAS VERY UPSET AS HE WAS IN LOT OF PAIN. WHEN THE PT TOLD ABOUT THIS TO THE DOCTOR, THE DOCTOR SAID "HE WAS BEING PARANOID AND IT MIGHT BE DUE TO A KIDNEY STONE OR SOMETHING". THE PT REPORTED THAT IF HE KNEW THAT "SYNVISC WAS FROM ROOSTER COMBS, HE WOULD HAVE NOT GOTTEN IT IN THE FIRST PLACE." ACTION TAKEN: NO ACTION TAKEN (THE PT RECEIVED ALL THREE INJECTIONS OF THE SERIES). CORRECTIVE TREATMENT: MORPHINE SULFATE (MS CONTIN) AND HYDROMORPHONE HYDROCHLORIDE (DILAUDID) FOR THE EVENT OF PAINFUL INJECTION. OUTCOME FOR ALL THE EVENTS: UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568617 SYNVISC INTRA-ARTICULA HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other CON MEDS = UNK| PREV MEDS = UNK