BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPARTZ

    MDR report key: 3830077 · Received May 23, 2014

    Report

    Report Number
    9612392-2014-00005
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    March 20, 2014
    Report Date
    April 8, 2014
    Manufacturer
    SEIKAGAKU CORPORATION
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE UNDER INVESTIGATION IN DETAILS. NO CASE HAS BEEN REPORTED FROM OTHER FACILITIES ON THE REPORTED BATCH NUMBER. NO PROBLEM ON MANUFACTURING RECORDS, RELEASE TEST RESULTS AND MONITORING RECORDS AT MANUFACTURING SITES. WE CONSIDER THAT THE PRODUCT QUALITY IS NOT RELATED TO THE EVENT.

    Description of Event or Problem · 1

    (B)(6) 2014 - A (B)(6) MALE PATIENT RECEIVED 1ST INJECTION OF SUPARTZ IN THE RIGHT KNEE OF OSTEOARTHRITIS. TOLERATED WELL. (B)(6) 2014 - HE RECEIVED 2ND INJECTION OF SUPARTZ IN THE RIGHT KNEE. TOELRATED WELL. (B)(6) 2014 - HE RECEIVED 3RD INJECTION OF SUPARTZ IN THE RIGHT KNEE. (B)(6) 2014 - HE NOTICED THE SWELLING. HE SOUGH MEDICAL ATTENTION AND HE KNEE WAS WASHED AND FOUND TO CONTAIN GRAM (+) COCCI. HE WAS GIVEN ANTIBIOTICS (KEFLEX). THIS EVENT REQUIRED PATIENT HOSPITALIZATION WITH ONGOING PROCEDURES (NOT SPECIFIED). HE IS STILL HOSPITALIZED AND THE PHYSICIAN IS NOT YET SURE OF THE DIAGNOSIS BUT MENTIONED THAT THE REACTION IS RELATED TO THE INJECTION. THE PHYSCIAN DOES NOT USE ULTRASOUND OR X-RAY TO ASSIST WITH ADMINISTERING THE INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308454 SUPARTZ ACID, HYALURONIC, INTRAARTICULAR MOZ SEIKAGAKU CORPORATION NA 3A657N

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization