BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIUMPH

    MDR report key: 2466954 · Received February 22, 2012

    Report

    Report Number
    2466954
    Event Type
    Other
    Date Received
    February 22, 2012
    Date of Event
    February 22, 2012
    Report Date
    February 22, 2012
    Manufacturer
    MEDLINE INDUSTRIES
    Product Code
    KGO
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    JUST PRIOR TO THE NURSE DONNING STERILE GLOVES FOR A PATIENT IN THE CARDIAC CATH LAB, SHE NOTED A BLACK BUG IN ONE OF THE STERILE GLOVES.======================MANUFACTURER RESPONSE FOR STERILE, LATEX, POWDER FREE SURGICAL GLOVES. SIZE 6, TRIUMPH (PER SITE REPORTER).======================AWAITING RESPONSE BACK FROM QUALITY DEPARTMENT TO SEE IF THEY WOULD LIKE THE ITEM RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIUMPH STERILE, LATEX, POWDER FREE SURGICAL GLOVES. SIZE 6 KGO MEDLINE INDUSTRIES * 2011-091

    Patients

    Seq Age Sex Outcome Treatment
    1