BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOLUBE-III

    MDR report key: 3030775 · Received March 27, 2013

    Report

    Report Number
    1045834-2013-01022
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 4, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    GEY
    PMA / PMN Number
    K970530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. THE DEVICE WAS EVALUATED AND THE EVENT WAS DUPLICATED. EVIDENCE INDICATES THIS IS DUE TO USAGE WEAR OVER TIME. THE EVENT WAS CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THERE WAS "LIQUID DISCOVERED INSIDE THE DEVICE". THE REPORTER STATED THAT IT WAS UNKNOWN WHAT TYPE OF LIQUID WAS IN THE DEVICE. THE DEVICE WAS NOT BEING USED IN SURGERY. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125271 AUTOLUBE-III GEY THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1