BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYALURONIC ACID

    MDR report key: 5506551 · Received March 17, 2016

    Report

    Report Number
    9610200-2015-00007
    Event Type
    Injury
    Date Received
    March 17, 2016
    Date of Event
    November 5, 2014
    Report Date
    March 17, 2016
    Manufacturer
    FIDIA FARMACEUTICI S.P.A.
    Product Code
    MOZ
    PMA / PMN Number
    P950027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011017 ON 28 NOVEMBER 2011, THE FDA GRANTED THE PERMISSION FOR THE MANUFACTURER FIDIA FARMACEUTICI S.P.A. TO SUBMIT A SINGLE MDR FOR ADVERSE EVENTS THAT INVOLVE MEDICAL DEVICES MANUFACTURED BY FIDIA FARMACEUTICI S.P.A. AND IMPORTED INTO THE USA BY FIDIA PHARMA USA, INC. AS A CONSEQUENCE, FIDIA FARMACEUTCI S.P.A. (THE MANUFACTURER) IS SUBMITTING THIS REPORT EVEN ON BEHALF OF FIDIA PHARMA USA INC (THE IMPORTER). THE PRESENT MDR REPORT SATISFIES THE REPORTING OBLIGATIONS FOR BOTH COMPANIES. THE CASE IS OF DIFFICULT EVALUATION DUE TO THE INCOMPLETE INFORMATION. FIDIA FARMACEUTICI RECEIVED IN COPY THIS INFORMATION ON THE CASE BY ANOTHER PHARMACEUTICAL COMPANY ((B)(4)). ANY ATTEMPS HAVE BEEN CARRIED OUT TO VERIFY THE HYALURONIC ACID BASED-PRODUCT INVOLVED IN THE SUSPECT ADRS BUT ANY EFFORT WAS UNSUCCESSFUL. THE CONSUMER DIDN'T WANT NEITHER TO GIVE FURTHER INFORMATION NOR THE PERMISSION TO CONTACT HER PHYSICIAN. CONSERVATEVELY THE CASE HAS BEEN SUBMITTED TO THE FDA CONSIDERING THE AE AS IF IT WAS OCCURRED WITH FIDIA'S PRODUCT (HYALGAN). THE RELATIONSHIP OF HYALGAN WITH THE HYPERTENSION, OXYGEN DESATURATION AND SICKNESS WAS DEEMED POSSIBLE ACCORDING TO A TEMPORAL ALGORITHM. THE RELATIONSHIP OF HYALGAN WITH THE THYROIDECTOMY AND THE WEIGHT GAIN IS DEEMED FOR BOTH UNASSESSABLE DUE TO THE PAUCITY OF THE INFORMATION. THE CASE IS NOTIFIED LATE DUE TO THE TECHNICAL PROBLEMS DURING THE TEST PHASE FOR THE ELECTRONIC SUBMISSION AS WEBTRADER. THE DEVICE IS NOT AVAILABLE.

    Description of Event or Problem · 0

    THIS SPONTANEOUS, SERIOUS ADVERSE EVENT WAS REPORTED BY A (B)(6) FEMALE PATIENT VIA ANOTHER PHARMACEUTICAL COMPANY'S PATIENT SUPPORT PROGRAM. ON AN UNKNOWN DATE THE PATIENT RECEIVED UNKNOWN HYALURONIC GEL INJECTIONS OF AN UNKNOWN DOSE AND FREQUENCY INTO HER KNEES FOR AN UNKNOWN INDICATION. ON 02/SEP/2015 THE PATIENT REPORTED THAT SHE BEGAN TREATMENT WITH LOVAZA IN 2005 FOR THE TREATMENT OF HIGH TRIGLYCERIDES. THE PATIENT NOTED HER CONCOMITANT MEDICATIONS AT THE TIME TO BE SYNTHROID, DICLOFENAC AND THE UNKNOWN HYALURONIC GEL. THE PATIENT REPORTED THAT ON (B)(6) 2014 SHE UNDERWENT A PARTIAL THYROIDECTOMY AND SUBSEQUENTLY GAINED 22 POUNDS. ON (B)(6) 2015 THE PATIENT GOT SICK AND ON (B)(6) 2015 SHE PRESENTED TO THE EMERGENCY ROOM. THE PATIENT'S BLOOD PRESSURE WAS SO HIGH IT WAS TO A STROKE LEVEL AND HER OXYGEN SATURATION DROPPED. THE LOT NUMBER AND EXPIRATION DATE OF THE UNKNOWN HYALURONIC ACID GEL INJECTIONS ARE UNKNOWN. AS OF (B)(6) 2015 IT WAS UNKNOWN WHETHER THE PATIENT CONTINUED TO RECEIVE THE UNKNOWN HYALURONIC ACID GEL INJECTIONS AND THE OUTCOME OF THYROIDECTOMY, WEIGHT GAIN, SICKNESS, BLOOD PRESSURE HIGH AT STROKE LEVEL, AND OXYGEN SATURATION DECREASED WAS UNKNOWN. THE PATIENT REPORTED THAT THESE EVENTS HAD NOTHING TO DO WITH LOVAZA THOUGH SHE WAS NOT TAKING AS MUCH AS SHE SHOULD, BUT COULD BE A RESULT OF A COMBINATION OF MEDICATIONS THAT SHE RECEIVED INCLUDING SYNTHROID, DICLOFENAC, AND HYALURAONIC GEL INJECTED INTO HER KNEES. THE PATIENT DENIED AUTHORIZATION TO CONTACT HER PHYSICIAN AND REQUESTED TO NOT BE CONTACTED AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164691 HYALURONIC ACID INTRA-ARTICULAR INJECTION MOZ FIDIA FARMACEUTICI S.P.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other DICLOFENAC| LEVOTHYROXINE (SYNTHROID)| OMEGA-3-ACID ETHYL ESTERS (LOVAZA)| LEVOTHYROXINE (SYNTHROID)