BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOLUBE-III WITH IRRIGATION

    MDR report key: 3955398 · Received December 13, 2013

    Report

    Report Number
    1045834-2013-13908
    Event Type
    Malfunction
    Date Received
    December 13, 2013
    Report Date
    April 20, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GEY
    PMA / PMN Number
    K970530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROCESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED OR ADDITIONAL INFO BECOMES AVAILABLE, A SUPPLEMENT REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) STATING THAT SERVICE WAS REQUIRED FOR THE DEVICE. DURING SERVICE HOSE DAMAGE WAS NOTED. IT IS UNK IF THE DEVICE WAS USED IN SURGERY. IT IS UNK IF INJURY OR MED INTERVENTION OCCURRED. THE DATE OF THE EVENT IS UNK. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654118 AUTOLUBE-III WITH IRRIGATION GEY DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1