BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTGOWN, XX-LARGE/X-LONG, RAGLAN

    MDR report key: 7118040 · Received December 14, 2017

    Report

    Report Number
    1423537-2017-00141
    Event Type
    Injury
    Date Received
    December 14, 2017
    Date of Event
    November 20, 2017
    Report Date
    December 14, 2017
    Manufacturer
    QUIROPRODUCTOS DE CUAUHTEMOC S. DE R.L. DE C.V.
    Product Code
    FYA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CARDINAL HEALTH IS PROACTIVELY FILING THIS MEDWATCH. IT IS NOT KNOWN WHICH PRODUCT THE PHYSICIAN/SURGEON REACTED TO, BUT THE GOWN IS ONE OF THE PRODUCTS HE USED. THE LOT NUMBER WAS PROVIDED, THEREFORE THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO QUALITY ISSUES WERE REPORTED. THE SAMPLE WAS NOT AVAILABLE. WITHOUT THE SAMPLE, WE CANNOT IDENTIFY A ROOT CAUSE. WE WILL CONTINUE TO MONITOR FOR COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 1

    PHYSICIAN/SURGEON STARTED OFF WITH HAVING A BREAKOUT ON HIS HANDS THAT MOVED UP HIS ARMS. HE SWITCHED SCRUB SOAP, AND IT HELPED FOR A WHILE. THE SURGEON HAS BEEN USING THIS GOWN, IT IS NOT THE FIRST TIME THAT HE WORE IT. THEY ARE NOT SURE WHAT IS CAUSING HIS REACTION. SURGEON SAW AN ALLERGIST AND HAD TESTING DONE. CARDINAL HEALTH IS PROACTIVELY FILING THIS MEDWATCH SINCE THE GOWN WAS ONE OF THE PRODUCTS THE SURGEON USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895985 SMARTGOWN, XX-LARGE/X-LONG, RAGLAN GOWN, SURGICAL FYA QUIROPRODUCTOS DE CUAUHTEMOC S. DE R.L. DE C.V. 17JTC180

    Patients

    Seq Age Sex Outcome Treatment
    1 Other