BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYALGAN

    MDR report key: 3807431 · Received April 28, 2014

    Report

    Report Number
    9610200-2014-00010
    Event Type
    Injury
    Date Received
    April 28, 2014
    Date of Event
    May 1, 2012
    Report Date
    April 14, 2014
    Manufacturer
    FIDIA FARMACEUTICI SPA
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER: (B)(4) 2011, THE FDA GRANTED THE PERMISSION FOR THE MANUFACTURER FIDIA (B)(4). TO SUBMIT A SINGLE MDR FOR ADVERSE EVENTS THAT INVOLVE MEDICAL DEVICES MANUFACTURED BY FIDIA (B)(4) AND IMPORTED INTO THE USA BY FIDIA PHARMA USA, INC. AS A CONSEQUENCE, FIDIA (B)(4). (THE MANUFACTURER) SHOULD SUBMIT REPORTABLE CASES ON BEHALF OF FIDIA PHARMA USA INC (THE IMPORTER). HOWEVER, SINCE THIS IS A NON-US CASE OF WHICH FIDIA (B)(4) HAS BECOME AWARE IN ITS ROLE OF PRODUCT MANUFACTURER, FIDIA PHARMA USA DOES NOT HAVE ANY REPORTING OBLIGATION. FIDIA FARMACEUTICI SPA COMMENTS: NO BATCH NUMBER WAS RECEIVED ON THIS COMPLAINT; THEREFORE, NO INVESTIGATION CAN BE CONDUCTED. NO FURTHER INFO IS EXPECTED FOR THIS CASE. CONCLUSION: NO INVESTIGATION/NO ASSESSMENT POSSIBLE. CASE STATUS: CLOSED.

    Description of Event or Problem · 1

    AS A RESULT OF THE SAFETY DATA RECONCILIATION PROCESS BETWEEN FIDIA (B)(4) AND ITS WORLDWIDE BUSINESS PARTNERS, 8 SERIOUS INDIVIDUAL CASE-SAFETY REPORTS REGARDING HYALGAN HAVE BEEN IDENTIFIED. ALL THESE CASES WERE RECORDED IN (B)(6) BETWEEN 2005 AND 2013. ALL LEGAL REQUIREMENTS APPLICABLE TO MARKETING AUTHORIZATION HOLDERS IN THE (B)(4) HAVE BEEN FULFILLED BY THE LOCAL LICENSEE. FIDIA IS REPORTING THESE CASES AS MANUFACTURER AND KEEPER OF THE GLOBAL SAFETY DATABASE FOR THE PRODUCT. CASE 7 OF 8. SPONTANEOUS REPORT, LOCAL REFERENCE # (B)(4). INITIAL INFO RECEIVED ON (B)(46) 2012. A FEMALE BORN IN 1947, RETIRED PHYSICAL EDUCATION TEACHER, WITH MEDICAL HISTORY OF ARTHROSIS WITH KNEE PAIN IN BOTH KNEES AND RIGHT TIBIAL OSTEOTOMY IN 2002, RECEIVED HYALGAN SOLUTION FOR INJECTION (HYALURONIC ACID), 2 INJECTIONS IN TOTAL IN BOTH KNEES FOR ARTHROSIS. THE PATIENT RECEIVED THE FIRST INJECTION IN FEB(B)(6) 2012 FOLLOWED BY 2 WEEKS OF 47 DEGREES C HOT MUD APPLICATION AND THE SECOND INJECTION IN (B)(6) 2012., THE PATIENT DEVELOPED KNEE PAIN AND KNEE WEAKNESS AFTERWARDS. AFTER THE SECOND INJECTION IN (B)(6) 2012, CRUTCHES WERE PRESCRIBED. THE PATIENT DEVELOPED SEVERE KNEE PAIN MAINLY IN THE LEFT KNEE (ESPECIALLY WHEN TURNING ON SIDE IN BED) AND KNEES SWELLING AFTERWARDS, A MRI WAS PERFORMED ON (B)(6) 2012 AND SHOWED "WHITE ALL AROUND KNEE BONE." IN RESPONSE TO THE REACTIONS, THE PATIENT WAS ADVISED BY THE PHYSICIAN TO CONTINUE TO WALK AND USE CRUTCHES. IN (B)(6) 2012, THE PATIENT NOTICED THAT SHE COULD NOT STRETCH OUT HER LEGS ANYMORE DESCRIBED AS HALF-BENT LEG. AT THE END OF (B)(6) 2012, THE PATIENT STARTED A NATURAL TREATMENT WITH SILICA AMONG OTHERS. THE PATIENT HAD NOT YET RECOVERED FROM KNEES WEAKNESS, KNEES PAIN, SWELLING OF KNEES AND STIFFNESS. FOLLOW-UP INFO RECEIVED ON (B)(6) 2012 FROM THE REPORTING CONSUMER, AND ON (B)(6) 2012 FROM THE PRESCRIBING PHYSICIAN UPON PHONE CALLS. ACCORDING TO THE REPORTING CONSUMER, IN (B)(6) 2012 THE PATIENT RECEIVED SYNVISC-ONE (HYLANE G-F 20) FOR ARTHROSIS (NOT HYALGAN AS PREVIOUSLY REPORTED) FOLLOWED BY KNEE WEAKNESS AND KNEE PAIN. AT THE TIME OF THE REPORT, THE PATIENT HAD NOT YET RECOVERED AND STILL HAD A LIMP. ACCORDING TO THE REPORTING PHYSICIAN, HYALGAN WAS ADMINISTERED ON (B)(6) 2012. THE PRESCRIBING PHYSICIAN SAW THE PATIENT ON (B)(6) 2012 AND AS SHE WAS UNWELL, AN MRI WAS PRESCRIBED. THE PHYSICIAN DID SEE NEITHER THE PATIENT NOR THE MRI RESULT AT THE REPORTING TIME. ACCORDING TO THE PHYSICIAN, THE PATIENT HAD SEVERAL OTHER CAUSES WHICH COULD EXPLAIN THE PATIENT KNEE INFLAMMATORY FLARE UP BUT HYALGAN COULD NOT BE RULED OUT. FOLLOW-UP INFO RECEIVED ON (B)(6) 2012 FROM THE REPORTING PHYSICIAN UPON A LETTER. THE PHYSICIAN DID NOT SEE THE PATIENT SINCE THE APPOINTMENT IN (B)(6) 2012 AND DID NOT HAVE FURTHER INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254505 HYALGAN HYALURONIC ACID FOR INTRARTICULAR USE MOZ FIDIA FARMACEUTICI SPA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability