BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSONIX HOOK PROBE LONG

    MDR report key: 2974175 · Received February 15, 2013

    Report

    Report Number
    1219930-2013-00093
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    October 12, 2012
    Report Date
    January 17, 2013
    Manufacturer
    COVIDIEN, FORMERLY U.S. SURGERY
    Product Code
    GDW
    PMA / PMN Number
    K971861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LUMBAR PUNCTURE. ACCORDING TO THE REPORTER: A NEEDLE BROKE OFF IN THE PT'S LOWER SPINE DURING A LUMBAR PUNCTURE PROCEDURE. T...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69505 AUTOSONIX HOOK PROBE LONG DISPOSABLE SURGICAL DEVICE GDW COVIDIEN, FORMERLY U.S. SURGERY N2E0031X

    Patients

    Seq Age Sex Outcome Treatment
    1