BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR

    MDR report key: 2980103 · Received February 21, 2013

    Report

    Report Number
    1045834-2013-00299
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 25, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    ERL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT WAS RECEIVED FROM THE USA REQUESTING FOR AN UNIDENTIFIED REPAIR. IT WAS UNKNOWN TO THE REPORTER WHETHER OR NOT THE DEVICE WAS USED IN SURGERY. THERE WERE NO INJURIES OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75464 XMAX MOTOR ERL THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1