BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 1891058 · Received October 29, 2010

    Report

    Report Number
    2523835-2010-00124
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 16, 2010
    Manufacturer
    ALCON PRECISION DEVICE - SINKING SPRING
    Product Code
    HNN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THE KNIVES WERE DULL. NO PT IMPACT WAS REPORTED. ADDITIONAL INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING 8065982465 809435M

    Patients

    Seq Age Sex Outcome Treatment
    1