BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR, HIGH STRENGTH HOSE

    MDR report key: 3080991 · Received April 24, 2013

    Report

    Report Number
    1045834-2013-02022
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    ERL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REPORT RECEIVED FROM SYNTHES CANADA STATING THAT DURING AN INVENTORY INSPECTION, IT WAS OBSERVED THAT THE DEVICE HAD A "HOLE IN THE HOSE NEAR THE HANDPIECE" AND THE DEVICE WAS "LEAKING AN OILY SUBSTANCE." THE DEVICE WAS NOT USED IN SURGERY. THERE WERE NO INJURIES OR MEDICAL INTERVENTION REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176420 XMAX MOTOR, HIGH STRENGTH HOSE ERL THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1