BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPARTZ

    MDR report key: 3012455 · Received March 15, 2013

    Report

    Report Number
    9612392-2013-00001
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    December 6, 2012
    Report Date
    February 21, 2013
    Manufacturer
    SEIKAGAKU CORP.
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THIS IS A DEFINITIVE REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2012 - (B)(6) MALE PATIENT RECEIVED THE 1ST SUPARTZ INJECTION IN THE LEFT KNEE FOR OSTEOARTHRITIS. HE TOLERATED WELL. ON (B)(6) 2012 - HE RECEIVED THE 2ND SUPARTZ INJECTION IN THE LEFT KNEE. TOLERATED WELL. ON (B)(6) 2012 - HE RECEIVED THE 3RD INJECTION IN THE LEFT KNEE. AT NIGHT THE PATIENT EXPERIENCED SEVERE PAIN AND SWELLING. ON (B)(6) 2012 - HE REPORTED THE INCIDENT TO HIS INJECTION PHYSICIAN AND WAS SEEN AT THE INJECTION PHYSICIAN OFFICE FOR A FOLLOW VISIT THAT SAME DAY. THE INJECTION PHYSICIAN DRAINED 80CC OF FLUID FROM THE KNEE AND SENT IT TO THE HOSPITAL FOR TESTING. NO BACTERIA OR INFECTION WAS REPORTED FROM THE TESTING. THE FLUID DID LOOK YELLOW AND CLOUDY. THE SWELLING WENT DOWN. THAT SAME DAY THE PATIENT CALLED AFTER HOURS AND STATED THAT HE HAS SEVERE PAIN. THE INJECTION PHYSICIAN THEN RECOMMENDED HIM TO GO TO THE E.R. AT THE E.R., THE PATIENT WCB WAS FOUND TO BE NORMAL AND NO SIGN OF INFECTION WAS FOUND. THE ORTHOPEDIC AT THE E.R. DECIDED TO ADMIT HIM AT THE HOSPITAL FOR 5 DAYS BECAUSE HE IS AN ELDERLY AND LIVES ALONE. THE INJECTION PHYSICIAN SAID THAT FROM HIS CONVERSATION WITH THE E.R. ORTHOPEDIC, THE ORTHOPEDIC STATED THAT HE WOULD DISCHARGE OF THE PATIENT BUT SINCE HE HAS NO FAMILY TO TAKE CARE OF HIM HE DECIDED TO KEEP HIM LONGER. ON (B)(6) 2013 - THE INJECTION PHYSICIAN REPORTED THAT THE PATIENT WAS PRESCRIBED TRAMADOL AND HAS CONTINUED TO HAVE PHYSICAL THERAPY. HE ALSO HAS CONTINUOUS INFUSION FROM OA AS HE HAD THIS BEFORE THE INJECTION. THE PATIENT HAD RECOVERED AND THE INJECTION PHYSICIAN DECIDED TO DISCONTINUE THE SUPARTZ TREATMENT FOR THIS PATIENT. THE E.R. AND THE INJECTION PHYSICIAN SUSPECT A REACTION TO SUPARTZ INJECTION. THE INJECTION PHYSICIAN SUSPECTS NO CAUSALITY WITH KENALOG INJECTION AND IT WAS ADMINISTERED TO THE PATIENT ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110423 SUPARTZ SODIUM HYALURONATE MOZ SEIKAGAKU CORP. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| O KENALOG (TRIAMCINOLONE), CATALOG # UNK