BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-RADIOFREQUENCY CABLE

    MDR report key: 2954017 · Received February 11, 2013

    Report

    Report Number
    1033422-2013-00012
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 3, 2013
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE DEVICE HISTORY RECORD AND THE ANALYSIS OF THE RETURNED DEVICE ARE PENDING. WE ARE UNABLE TO DETERMINE A ROOT CAUSE AT THIS TIME, AS THE INVESTIGATION IS ONGOING. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE DHR REVIEW OR ONCE SAMPLES ARE EVALUATED, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT STATING, "DURING PROCEDURE, THE PHYSICIAN WAS NOT ABLE TO GET A TEMP READING FROM THE PROBE. PROCEDURE HAD TO BE ABORTED. NO PT INJURY." KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE KIMBERLY-CLARK COMPLAINT DATABASE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57898 MULTI-RADIOFREQUENCY CABLE RF CABLE DRF KIMBERLY-CLARK HEALTH CARE PXFA011209

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention