BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 2122457 · Received June 13, 2011

    Report

    Report Number
    2182208-2011-00707
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DRB
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN INCREASED INCIDENCE OF STAPHYLOCOCCUS EPIDERMIDIS, BETA-LACTAMASE OBTAINED AND DOCUMENTED FROM TESTING OF THE STYLET KITS. THE STYLETS WERE NOT USED WITH A PATIENT AND NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE STYLET DRB MEDTRONIC, INC. 6057 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other