BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDRAD CT INJECTOR

    MDR report key: 3240114 · Received July 18, 2013

    Report

    Report Number
    2520313-2013-00039
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 24, 2013
    Manufacturer
    MEDRAD
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) QUALITY ASSURANCE PRODUCT ANALYSIS REVIEWED THE INFORMATION THAT WAS PROVIDED BY THE SITE AND IS AWAITING THE RETURN OF THE EXTRAVASATION SENSOR/DETECTOR DEVICE IN ORDER TO CONDUCT AN INVESTIGATION. THE XDS EXTRAVASATION SENSOR/DETECTOR OPERATION MANUAL STATES THAT THE XDS SYSTEM IS VALIDATED FOR USE ON ADULTS IN ANTECUBITAL INJECTIONS ONLY. THE SITE HAD PLACED IT ON THE RIGHT HAND WHICH IS NOT AN INDICATED/INTENDED USE BY THE MANUFACTURER. IN THE EVENT ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE SITE REPORTED THE FOLLOWING: THE CUSTOMER REPORTED AN UNDETECTED EXTRAVASATION OF THE RIGHT HAND OCCURRED WHILE THE XDS EXTRAVASATION SENSOR/DETECTOR DEVICE WAS IN USE. THE PT SUFFERED EDEMA, DECREASED MOTION, PAIN AND PARASTHESIA. TISSUE NECROSIS WAS NOTED ON THE DORSAL ASPECT OF THE RIGHT HAND. THE PT UNDERWENT RECONSTRUCTIVE SURGERY FOR DECOMPRESSION OF THE MEDIAN NERVE AND DRAINAGE OF A COMPRESSIVE HEMATOMA WITH INDICATION FOR A SKIN TRANSPLANT/GRAFT TO FOLLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333086 MEDRAD CT INJECTOR CT INJECTOR DXT MEDRAD XDS PID

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention