BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 1001393 · Received February 20, 2008

    Report

    Report Number
    1056128-2008-00009
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    January 21, 2008
    Report Date
    February 20, 2008
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    NLQ
    PMA / PMN Number
    K043315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED A DEEP GOUGE IN THE AREA WHERE A PIECE OF THE TEFLON PAD DETACHED. THIS CONDITION SUGGESTS THAT THE DEVICE MADE CONTACT WITH A RIGID OBJECT. EVIDENCE SUPPORTS THE MOST LIKELY CAUSE FOR THIS EVENT IS MISHANDLING/MISUSE.

    Description of Event or Problem · 1

    THE WHITE TEFLON PAD DETACHED FROM THE DISTAL TIP OF THE DEVICE. THERE WAS NO SERIOUS INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA NLQ ASCENT HEALTHCARE SOLUTIONS ACE36P 141720

    Patients

    Seq Age Sex Outcome Treatment
    1