BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLV SURG ESTEEM NEU-THERA PF SYN SZ 7.0

    MDR report key: 2070975 · Received April 27, 2011

    Report

    Report Number
    1423537-2011-00021
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 27, 2011
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KGO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE OR LOT NUMBER WAS PROVIDED BY THE CUSTOMER, THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HISTORICAL TRENDING WAS DONE. THE PRODUCT PASSED THE REQUIREMENTS OF THE PRIMARY SKIN IRRITATION TEST PER THE TECHNICAL SERVICE REPORT. THE EXACT CAUSE OF THE SKIN IRRITATION COULD NOT BE DETERMINED. THE ESTEEM NEU-THERA GLOVE HAS PASSED A SERIES OF TESTS PRESCRIBED BY REGULATORY AGENCIES FOR THE INTENDED USE. HOWEVER, THE POSSIBILITY OF AN INDIVIDUAL EXPERIENCING A REACTION TO CERTAIN CHEMICALS USED DURING THE MANUFACTURING PROCESS CANNOT BE RULED OUT. WE WILL CONTINUE TO MONITOR COMPLAINTS FOR ANY TRENDS.

    Description of Event or Problem · 1

    PHYSICIAN WEARING GLOVES DURING OPERATIVE PROCEDURE COMPLAINED OF ITCHINESS TO HANDS AND THEN EXPERIENCED COUGH AND FEELING OF TIGHTNESS IN THROAT. PHYSICIAN WENT TO THE ER, WAS TREATED, AND ADMITTED OVERNIGHT FOR OBSERVATION. HE HAS RETURNED TO PRACTICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLV SURG ESTEEM NEU-THERA PF SYN SZ 7.0 SURGEON'S GLOVES KGO CARDINAL HEALTH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization