BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOP-DRAPE WARMER

    MDR report key: 643276 · Received October 9, 2005

    Report

    Report Number
    643276
    Event Type
    Malfunction
    Date Received
    October 9, 2005
    Date of Event
    September 1, 2005
    Report Date
    October 9, 2005
    Manufacturer
    O.R. SOLUTIONS, INC
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    OR STAFF OPENED SEALED STERILE DISPOSABLE WARMER DRAPE- FOUND HAIR ON DRAPE. ON FURTHER INSPECTION OF PACKAGE INSERT, THERE WAS NOT AN EXPIRATION DATE STICKER ON PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOP-DRAPE WARMER WARMER DRAPE MMI O.R. SOLUTIONS, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *