BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_ARRINEX_PRODUCT

    MDR report key: 9779404 · Received March 3, 2020

    Report

    Report Number
    3015132143-2020-00002
    Event Type
    Injury
    Date Received
    March 3, 2020
    Date of Event
    January 31, 2020
    Report Date
    March 3, 2020
    Manufacturer
    ARRINEX, INC.
    Product Code
    GEH
    PMA / PMN Number
    162608
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    RECEIVED EMAIL THAT CLARIFIX PATIENT HAD TO GO BACK TO OPERATION ROOM DUE TO SPA BLEED. NO OTHER INFORMATION COULD BE OBTAINED THROUGH MULTIPLE ATTEMPTS TO CONTACT PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244040 UNKNOWN_ARRINEX_PRODUCT CRYOABLATION DEVICE GEH ARRINEX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention