BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KNIFE

    MDR report key: 1712848 · Received June 4, 2010

    Report

    Report Number
    2028159-2010-00817
    Event Type
    Injury
    Date Received
    June 4, 2010
    Date of Event
    April 5, 2010
    Report Date
    May 6, 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
    HI, US
    Reporter Occupation
    UNKNOWN

    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 INFORMATION BECOMES AVAILABLE. (B) (4). (B) (4). (B) (4).

    Description of Event or Problem · 1

    ADVERSE EVENTS(S): "PATIENT IMPACT IS UNKNOWN" (NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT). PRODUCT PROBLEM(S): "COULD NOT REMEMBER THE ACTUAL COMPLAINT OR DISSATISFACTION" (NO KNOWN DEVICE PROBLEM). A KNIFE WAS RETURNED ALONG WITH A REPLY CARD STATING THE LOT NUMBER IS UNKNOWN AND THAT THE EVENT HAPPENED DURING A PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED FROM THE FACILITY. ADDITIONAL INFORMATION WAS RECEIVED. THE INITIAL REPORTER REPORTED SHE COULD NOT REMEMBER ANY DETAILS OF THE EVENT. PATIENT IMPACT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING 8065921540 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other