BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYALURONIC ACID

    MDR report key: 3250441 · Received July 10, 2013

    Report

    Report Number
    9610200-2013-00004
    Event Type
    Injury
    Date Received
    July 10, 2013
    Manufacturer
    UNKNOWN
    Product Code
    MOZ
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER (B)(4). ON 11/28/2011, 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 (B)(4). AND IMPORTED INTO THE USA BY FIDIA PHARMA USA, INC. AS A CONSEQUENCE, (B)(4). (THE MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4). (THE IMPORTER). THE PRESENT MDR REPORT (COMING FROM LITERATURE) SATISFIES THE REPORTING OBLIGATIONS FOR BOTH COMPANIES. PHARMACOVIGILANCE COMMENT: THIS IS A SPONTANEOUS CASE REPORT BY LITERATURE FOR WHICH THE COMMERCIAL NAME OF THE PRODUCT HYALURONIC ACID-BASED THAT CAUSED THE ADVERSE EVENTS WAS NOT IDENTIFIED. IN THIS PATIENT, HA MATERIAL WAS FOUND INTO THE DEEP VESSELS. IN THE LITERATURE HAVE BEEN REPORTED CASE OF ADVERSE REACTIONS TO INJECTABLE SOFT TISSUE FILLERS. IN THIS CASE, IT SEEMS THAT THE EVENTS OCCURRED FOLLOWING TO AN ACCIDENTAL INJECTION OF HYALURONIC ACID INTO THE VESSELS.

    Description of Event or Problem · 1

    PLEASE REFER IMPORTER REPORT 3009107511-2013-00004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316300 HYALURONIC ACID HYALURONIC ACID MOZ UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1