BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSHING NERVE HOOK

    MDR report key: 18536772 · Received January 18, 2024

    Report

    Report Number
    1423507-2024-01003
    Event Type
    Malfunction
    Date Received
    January 18, 2024
    Date of Event
    November 10, 2023
    Report Date
    January 18, 2024
    Manufacturer
    CAREFUSION INC.
    Product Code
    HAO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    V.MUELLER IS NOT THE MANUFACTURER OF THE CUSHING NERVE HOOK SUBJECT OF REPORTED EVENT. STERIS HAS NOTIFIED THE MANUFACTURER AVALIGN TECHNOLOGIES, INC. OF THE REPORTED EVENT TO INTERNALLY INVESTIGATE AND EVALUATE FOR REPORTABILITY IN ACCORDANCE WITH 21 CFR PART 803. IT SHOULD BE NOTED THAT STERIS IS SUBMITTING A MEDICAL DEVICE REPORT (MDR) SOLELY DUE TO THE RECEIPT OF THE USER FACILITY MEDWATCH REPORT WHICH IS IN ACCORDANCE WITH OUR POLICIES AND PROCEDURES. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED VIA MEDWATCH MW5148469 "TIP OF MICRO NERVE HOOK BROKE OFF IN SURGICAL SITE. PIECE WAS ABLE TO BE RETRIEVED AND WITH NO DAMAGE TO SURROUNDING VESSELS." NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867877 CUSHING NERVE HOOK CUSHING NERVE HOOK HAO CAREFUSION INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown