BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESOPHAGEAL MANOMETRY CATHETER

    MDR report key: 7797303 · Received August 17, 2018

    Report

    Report Number
    MW5079232
    Event Type
    Malfunction
    Date Received
    August 17, 2018
    Date of Event
    August 14, 2018
    Report Date
    August 16, 2018
    Manufacturer
    DIVERSATEK HEALTHCARE, INC. / SANDHILL SCIENTIFIC, INC.
    Product Code
    KLA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FOLLOWING USE, THE DIVERSATEK HEALTHCARE / SANDHILL ESOPHAGEAL MANOMETRY CATHETER WAS NOTED TO HAVE EXPOSED COPPER WIRES BELOW THE MOST PROXIMAL CATHETER MARKER BEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636567 ESOPHAGEAL MANOMETRY CATHETER MANOMETRY CATHETER KLA DIVERSATEK HEALTHCARE, INC. / SANDHILL SCIENTIFIC, INC. UNI-ESO-WG1A1 K123245-E-1047-D

    Patients

    Seq Age Sex Outcome Treatment
    1