BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOWN PLASTIC FILM IMPERVIOUS

    MDR report key: 2503625 · Received March 26, 2012

    Report

    Report Number
    1423537-2012-00012
    Event Type
    Injury
    Date Received
    March 26, 2012
    Date of Event
    January 28, 2012
    Report Date
    March 26, 2012
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FME
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS NOT ABLE TO PROVIDE THE LOT NUMBER, THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HISTORICAL TRENDING WAS DONE. THE CUSTOMER ALSO WAS NOT ABLE TO PROVIDE THE SAMPLE. SINCE THERE WAS NO LOT NUMBER OR SAMPLE AVAILABLE, AN INVESTIGATION COULD NOT BE CONDUCTED TO DETERMINE IF THERE WAS ANY DEVIATION THAT COULD HAVE LED TO THIS COMPLAINT. THE ROOT CAUSE COULD NOT BE DETERMINED. THIS PRODUCT IS MADE OF (B)(4), AND HAS PASSED A SERIES OF TESTS PRESCRIBED BY REGULATORY AGENCIES FOR THE INTENDED USE. HOWEVER, THE POSSIBILITY OF SOME INDIVIDUAL EXPERIENCING A REACTION CAN NOT BE RULED OUT. RELEVANT PRODUCTION PERSONNEL WERE INFORMED OF THE COMPLAINT. WE WILL CONTINUE TO MONITOR COMPLAINTS FOR ANY SUCH ISSUES.

    Description of Event or Problem · 1

    THE NURSE, AFTER WEARING THE GOWN, NOTED A RASH ON HER NECK AND LEFT SIDE OF FACE. SCATTERED BLOTCHY AREAS WERE NOTED ON HER ARMS ALONG WITH ITCHING. TWO HOURS AFTER THE INITIAL REACTION, SHE DEVELOPED MORE EXTENSIVE HIVES AND WHEEZING. SHE WENT TO THE EMERGENCY ROOM WHERE SHE RECEIVED IV BENADRYL, IV SOLU-MEDROL, AND IV PEPCID. UPON DISCHARGE, SHE WAS GIVEN PRESCRIPTIONS FOR ATARAX, PEPCID, AND PREDNISONE. SHE ALSO HAD AN EPISODE WHERE SHE BRUSHED UP AGAINST SOMEONE WEARING THE GOWN, AND DEVELOPED HIVES AT THE SITE. THE NURSE HAS BEEN SENT TO EMPLOYEE HEALTH FOR FURTHER EVALUATION, AND MAY BE SEEING AN ALLERGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOWN PLASTIC FILM IMPERVIOUS GOWN, EXAMINATION FME CARDINAL HEALTH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other