BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYALURONIC ACID

    MDR report key: 3250526 · Received July 10, 2013

    Report

    Report Number
    3009107511-2013-00004
    Event Type
    Injury
    Date Received
    July 10, 2013
    Report Date
    July 2, 2013
    Manufacturer
    UNKNOWN
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT BY LITERATURE (JAMA DERMATOL MARCH 2013, VOL 149 (3): 373-375) WHICH REFERS TO A MALE PATIENT AGED 63 YEARS. THE PT HAD OSTEOARTHRITIS. THE PT HAD NO RELEVANT PAST MEDICAL HISTORY. THE PT HAD NO RELEVANT PAST DRUG HISTORY. ON UNSPECIFIED DATE THE PT RECEIVED INJECTIONS OF HYALURONIC ACID (HA) INTO BOTH KNEE JOINTS. ONE MONTH AFTER STARTED THE TREATMENT WITH THE SUSPECT PRODUCT, THE PT EXPERIENCED A SHARP PAIN BEHIND HIS RIGHT KNEE. RELEVANT LABORATORY AND INSTRUMENTAL TEST: SKIN BIOPSY SPECIMEN, DOPPLER ULTRASONOGRAPHY (BOTH LEGS), ECHOCARDIOGRAPHY, AND BLOOD ANALYSIS. THE AUTHORS HAVE HYPOTHESIZED A VASCULAR EMBOLISM AS CAUSE OF THE LIVEDO RETICULARIS WITH TWO NECROTIC AREAS. IN FACT THE SKIN BIOPSY SPECIMENS REVEALED DILATED BLOOD VESSELS IN THE RETICULAR DERMIS AND HYPODERMIS, WITH INTRA-ARTERIAL FOREIGN BODIES COMPOSED OF A BASOPHILIC AMORPHOUS MATERIAL THAT TESTED NEGATIVE UNDER PERIOD ACID-SCHIFF STAIN AND POSITIVE UNDER ALCIAN BLUE STAIN AT A PH OF 2.5. THE PT WAS TREATED FOR THE EVENT WITH LOW-MOLECULAR-WEIGHT HEPARIN TO PREVENT FURTHER EMBOLIC EVENTS AND SUSPECT PRODUCT WAS INTERRUPTED. ONE MONTH LATER, THE LESIONS STARTED TO FADE AND THE REACTION ABATED 6 MONTHS AFTER THE INJECTION. AT 1-YEAR FOLLOW-UP, TH PT WAS FREE OF LESIONS. AT THE TIME OF THIS REPORT, THE PT WAS TOTALLY RECOVERED. THE REPORTER CONSIDER THE EVENT CERTAINLY RELATED TO SUSPECT PRODUCT. THE REPORTER HAS NOT CONFIRMED THE COMMERCIAL NAME OF THIS HYALURONIC ACID BASED-PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317994 HYALURONIC ACID HYALURONIC ACID MOZ UNKNOWN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other