BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDRAD CT INJECTOR

    MDR report key: 1082233 · Received July 25, 2008

    Report

    Report Number
    2520313-2008-00015
    Event Type
    Other
    Date Received
    July 25, 2008
    Report Date
    July 25, 2008
    Manufacturer
    MEDRAD, INC.
    Product Code
    IZQ
    PMA / PMN Number
    K063090
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. THE CUSTOMER DISPOSED OF THE SENSOR INTERFACE DISPOSABLE (SID). THE EXACT LOT NUMBER OF THE TAPE IS UNKNOWN; HOWEVER, THE SITE PROVIDED A LOT NUMBER FROM THEIR CURRENT STOCK. RETAINED SAMPLES FROM THIS LOT NUMBER WERE SENT TO AN OUTSIDE LAB FOR ANALYSIS. THE RESULTS ARE PENDING.

    Description of Event or Problem · 1

    AFTER THE PATIENT'S CT SCAN WAS FINISHED, THE TECHNOLOGIST WENT TO REMOVE THE SENSOR INTERFACE DISPOSABLE (SID), USED WITH THE STELLANT EXTRAVASATION DETECTOR (XDS), FROM THE PATIENT'S ARM. BECAUSE THE PATIENT HAD LOOSE SKIN, THE TECHNOLOGIST WAS CAUTIOUS. THE TOP LAYER OF SKIN CAME OFF WITH THE TAPE - APPROXIMATELY A 1.5" X 2.0" AREA. THE RADIOLOGIST EXAMINED THE PATIENT AND FELT THAT IT WOULD HEAL BY ITSELF. THEY GAVE GAUZE, COBAN, AND INSTRUCTIONS TO THE PATIENT AND HER DAUGHTER TO CONTACT HER PHYSICIAN IF THEY SAW ANY SIGNS OF INFECTION. NO FURTHER TREATMENT WAS PROVIDED AT THAT TIME. IT WAS LATER REPORTED THAT THE PATIENT SAW HER FAMILY DOCTOR. HE EVALUATED THE PATIENT'S ARM AND ORDERED WOUND CARE TREATMENTS UNTIL IT HEALED. THE SPECIFICS OF THE EXACT WOUND CARE TREATMENTS ARE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDRAD CT INJECTOR CT INJECTOR IZQ MEDRAD, INC. XDS PID UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention