BEUDAMED
    FDA Adverse Event Other Summary report: N

    SURGICAL GOWNS

    MDR report key: 4478438 · Received January 30, 2015

    Report

    Report Number
    1055892-2014-00181
    Event Type
    Other
    Date Received
    January 30, 2015
    Date of Event
    December 30, 2014
    Report Date
    January 30, 2015
    Manufacturer
    STANDARD TEXTILE CO., INC.
    Product Code
    FYA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED GOWN WAS TESTED FOR PH, WHICH SHOWED TO BE NEUTRAL. CUFFS AND SLEEVES WERE SOAKED IN WARM WATER TO CHECK FOR PRESENCE OF EXCESSIVE DETERGENT RESIDUE (SUDSING) WHERE WATER APPEARED CLEAR AND SHOWED NO SIGNS OF EXCESSIVE DETERGENT RESIDUE. DAILY BOILER AND SOFTENER LOGS AND TITRATION REPORTS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM THE ORIGINAL SPECIFICATIONS. THE TITRATION REPORTS ALSO SHOWED NO DEVIATIONS FROM THE SPECIFICATIONS. A PH TEST AND AN EXCESSIVE DETERGENT RESIDUE CHECK ON PRODUCT THAT WAS RANDOMLY PULLED FROM ON-HAND INVENTORY MATCHED THE RETURNED GOWN TEST AND OBSERVATIONS RESULTS (NEUTRAL PH AND NO SUDSING OF WATER). TECHNICIAN HAS BEEN WEARING THE SAME TYPE GOWNS (REFERENCE MODEL #7004X) WITHOUT PROBLEMS SINCE (B)(6) 2015. BECAUSE WE CANNOT IDENTIFY ANY OTHER EVIDENCE OF A PROCESS DEVIATION AND BASED ON THE FACT THAT ALL OTHER RESULTS ARE WITHIN SPECIFICATIONS, AND HAVE NO OTHER COMPLAINTS BEING REPORTED, WE HAVE DETERMINED THAT THIS WAS AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    SURGICAL TECHNICIAN NOTICED WELTS AND HIVES ON BOTH WRISTS AND ARMS WHILE WEARING LP (LEVEL 4) SURGICAL GOWN. EMPLOYEE HEALTH DEPARTMENT PRESCRIBED AND ADMINISTERED ZYRTEC PILLS AND 1% HYDROCORTISONE CREAM TO ALLEVIATE ITCHING AND SWELLING/REDNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71948 SURGICAL GOWNS SURGICAL GOWNS FYA STANDARD TEXTILE CO., INC. 7004X 664471

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention