BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPRAHYAL

    MDR report key: 8755609 · Received July 2, 2019

    Report

    Report Number
    3003184440-2019-00002
    Event Type
    Injury
    Date Received
    July 2, 2019
    Date of Event
    May 9, 2019
    Report Date
    June 4, 2019
    Manufacturer
    TEDEC-MEIJI FARMA
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MANUFACTURER REPORTED THAT A FEMALE OF (B)(6) YEARS OLD WITH A MEDICAL HISTORY OF ARTHROSIS DEVELOPED SYNCOPE AFTER ADMINISTRATION OF SUPRAHYAL ON(B)(6) 2019 WITH CO-ADMINISTRATION OF PLATELET GROWTH FACTORS AND LIDOCAINE. NO PROBLEM WAS EVIDENT DURING THE FIRST 30 MINUTES. AFTER LEAVING THE MEDICAL FACILITY THE PATIENT DEVELOPED WEAKNESS AND SYNCOPE. A PHYSICIAN DECIDED SHE SHOULD BE OBSERVED IN THE EMERGENCY DEPARTMENT. THE PATIENT WAS OBSERVED AT THE EMERGENCY DEPARTMENT AND "LABORATORY STUDIES WERE NORMAL. AFTER 16 HOURS APPROXIMATELY THE PATIENT IS DISCHARGED, PATIENT DOES NOT REFER NEW SYMPTOMS OR NEW EPISODES. DATE OF RECOVERY: (B)(6). MEDICAMENTA ECUATORIANA PHARMACOVIGILANCE COMMENT: IN THE PATIENT IT IS DIFFICULT TO DETERMINE THE ETIOLOGY OF THE SYNCOPE BY THE FORM OF ADMINISTRATION. THE FACT OF USING A COMBINATION OF PRODUCTS IN THE SAME ROUTE CAN CAUSE NON-VISIBLE EFFECTS WITH EACH INDIVIDUAL PRODUCT. RELATEDNESS OF DRUG TO REACTION(S): MEDICINAL PRODUCT: SUPRAHYAL 25 MG X 1 INY X 1 JER SOLUCION INYECTABLE - DRUG REACTION ASSESS: SYNCOPE - SOURCE OF ASSESSMENT: TMF - METHOD OF ASSESSMENT: KARL-LASAGNA ALGORITHM (AMENDED) - CAUSALITY ASSESSMENT: POSSIBLE. MANUFACTURER'S COMMENT: THE CAUSAL ROLE OF SODIUM HYALURONATE IN THE EVENT DEVELOPED CANNOT BE RULED OUT AS WELL AS THE OTHER DRUGS ADMINISTERED IN THE SAME INJECTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549015 SUPRAHYAL SODIUM HYALURONATE MOZ TEDEC-MEIJI FARMA M-6

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization