BEUDAMED
    FDA Adverse Event Other Summary report: N

    VIDEO GUIDED CATHETER

    MDR report key: 2001071 · Received February 15, 2011

    Report

    Report Number
    1062474-2011-00001
    Event Type
    Other
    Date Received
    February 15, 2011
    Report Date
    February 14, 2011
    Manufacturer
    MYELOTEC, INC.
    Product Code
    HRX
    PMA / PMN Number
    K980734
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING A MEETING ((B)(4) 2011) WITH AN OUTSIDE CONSULTANT, IT WAS COMMUNICATED THAT MYELOTEC, INC. HAD A LAWSUIT ON THE INTERNET. THE INTERNET WAS SEARCHED AND A LAWSUIT ENTITLED, CARTER ET AL V. MYELOTEC, INC. WAS FOUND ON JUSTIA.COM DOCKETS AND FILINGS THAT WAS FILED ON (B)(4) 2011. THE NATURE OF THE SUIT WAS LISTED AS TORTS - INJURY - PERSONAL INJURY - PRODUCT LIABILITY. FURTHER RESEARCH REVEALED AN ARTICLE IN THE DAYTON DAILY NEWS ENTITLED, "FEDERAL LAWSUIT FILED AGAINST DAYTON DOCTOR". THE ARTICLE ALSO NAMED MYELOTEC, INC. IN A LAWSUIT THAT WAS FILED ON (B)(4) 2011. THE LAWSUIT INVOLVED SEVERAL PTS AND THE ALLEGED INJURIES RANGED FROM NUMBNESS TO INCONTINENCE. AS OF (B)(4) 2011, MYELOTEC, INC. HAS NOT BEEN CONTACTED OR NOTIFIED BY THE ATTORNEY OR REPS OF THE LAWSUIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIDEO GUIDED CATHETER CATHETER AND ARTHROSCOPE HRX MYELOTEC, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other