BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOVE SURGICAL PROTEXIS LATEX MICRO

    MDR report key: 2852793 · Received November 30, 2012

    Report

    Report Number
    1423537-2012-00043
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 30, 2012
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KGO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED THE LOT NUMBER, THEREFORE, THE DEVICE HISTORY RECORD WAS REVIEWED. IT SHOWED THAT THIS LOT WAS INSPECTED AND RELEASED IN COMPLIANCE WITH ALL INSPECTION REQUIREMENTS. HISTORICAL TRENDING WAS DONE. THE ACTUAL SAMPLE WAS NOT AVAILABLE FOR VISUAL OR PHYSICAL EVALUATION THEREFORE, WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED COMPLAINT. WE WILL CONTINUE TO MONITOR COMPLAINTS FOR ANY TRENDS.

    Description of Event or Problem · 1

    SURGEON REPORTED HOLE IN FOREFINGER DURING SURGICAL CASE (IMPLANT). SURGEON DID NOT NEED TO SEEK TREATMENT. THE PATIENT WAS GIVEN ROUTINE ANTIBIOTICS PRIOR TO THE START OF THE PROCEDURE, BUT HAD ADDITIONAL ANTIBIOTICS (BY IRRIGATION) DURING THE PROCEDURE DUE TO THE HOLE IN THE GLOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOVE SURGICAL PROTEXIS LATEX MICRO SURGEON'S GLOVE KGO CARDINAL HEALTH TS12080638

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other