BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERWAND¿ XL

    MDR report key: 18977785 · Received March 26, 2024

    Report

    Report Number
    18977785
    Event Type
    Malfunction
    Date Received
    March 26, 2024
    Date of Event
    September 25, 2023
    Report Date
    September 27, 2023
    Manufacturer
    ACCESS SCIENTIFIC, LLC
    Product Code
    OWL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE NEEDLE INSIDE THE POWERWAND KIT USED TO INJECT NUMBING MEDICATION DID NOT WORK. THE PLUNGER WOULD NOT MOVE TO INJECT MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499928 POWERWAND¿ XL PERIPHERAL CATHETER INSERTION KIT OWL ACCESS SCIENTIFIC, LLC 307132 2007149

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female