BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDLINE 3G VINYL GLOVES

    MDR report key: 1647160 · Received March 25, 2010

    Report

    Report Number
    MW5015320
    Event Type
    Other
    Date Received
    March 25, 2010
    Date of Event
    March 20, 2010
    Report Date
    March 25, 2010
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    OPF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER WEARING 3G CURAD VINYL GLOVES, HANDS BECAME RED, EXTREMELY DRY AND FORMED SORES THAT OPENED AND WERE BLEEDING. DATES OF USE: (B) (6) 2010 - (B) (6) 2010. DIAGNOSIS OR REASON FOR USE: PPE FOR RESIDENT CARE. EVENT ABATED AFTER USE STOPPED OR DOES REDUCTED? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDLINE 3G VINYL GLOVES VINYL GLOVES OPF MEDLINE INDUSTRIES INC. CUR 8326 MA904546686

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other