BEUDAMED
    FDA Adverse Event Other Summary report: N

    POWDER-FREE EXAM

    MDR report key: 97464 · Received June 3, 1997

    Report

    Report Number
    2084395-1997-00001
    Event Type
    Other
    Date Received
    June 3, 1997
    Date of Event
    May 10, 1997
    Report Date
    June 3, 1997
    Manufacturer
    SAFESKIN CORP.
    Product Code
    LYY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS HOSPITAL CHECKS FOR WATER LEAKS AS A SAFETY MEASURE. PER THE MDR RECEIVED AT SAFESKIN, 3 OF SIX GLOVES CHECKED IN ONE BATCH LEAKED. UNABLE TO TELL DEFINITELY IF THE PRODUCT SPECIFIED (PFE) IS THE PRODUCT THEY USED FROM THE INFORMATION GIVEN. IT DOES, HOWEVER, SEEM TO DESCRIBE THIS PRODUCT ("POWDERLESS LATEX GLOVES".)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWDER-FREE EXAM POWDER-FREE LATEX GLOVE LYY SAFESKIN CORP. 110 6297-T27

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other