BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKENVOYDA

    MDR report key: 12566017 · Received October 1, 2021

    Report

    Report Number
    3008114965-2021-00484
    Event Type
    Injury
    Date Received
    October 1, 2021
    Date of Event
    January 12, 2011
    Report Date
    September 6, 2021
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    DQY
    PMA / PMN Number
    K140080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS PROVIDED BY THE CUSTOMER. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITATION WAS REVIEWED: VARELA M, GAVRA M, ANDREOU A, KARAGIANNI I, ALEXIOU GA. SUBARACHNOID HEMORRHAGE SECONDARY TO RUPTURED POSTERIOR COMMUNICATING ARTERY ANEURYSM IN A CHILD. CHILDS NERV SYST. 2011 JUN;27(6):1015-7. DOI: 10.1007/S00381-011-1408-Y. EPUB 2011 FEB 12. PMID: 21318615. "OBJECTIVE AND METHODS: THE AUTHORS PRESENT THE CLINICAL AND NEURORADIOLOGICAL FINDINGS IN A (B)(6) CHILD WITH SUBARACHNOID AND INTRAVENTRICULAR HEMORRHAGE RELATED TO POSTERIOR COMMUNICATING ARTERY ANEURYSM. THE ANEURYSM WAS SUCCESSFULLY TREATED WITH ENDOVASCULAR COILING. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED CERENOVUS DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: A GUIDE CATHETER OF 6 F (ENVOY, CORDIS) OTHER CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: MICROCATHETER (EXCELSIOR C.L. 10 OF BOSTON SCIENTIFIC) UNK COILS ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: DURING HOSPITALIZATION, THE PATIENT DEVELOPED FEVER. BLOOD CULTURES WERE POSITIVE FOR STAPHYLOCOCCUS EPIDERMIDIS AND THE PATIENT RECEIVED VANCOMYCIN INTRAVENOUSLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1462465 UNKENVOYDA GUIDE CATHETER DQY MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other