BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAP ANTI-EMBOLISM STOCKINGS

    MDR report key: 6338689 · Received February 17, 2017

    Report

    Report Number
    6338689
    Event Type
    Malfunction
    Date Received
    February 17, 2017
    Date of Event
    January 18, 2017
    Report Date
    February 9, 2017
    Manufacturer
    CAROLON CO.
    Product Code
    DWL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE RN OBTAINED SUPPORT STOCKINGS FROM THE SUPPLY ROOM. WHEN IN THE ROOM WHILE OPENING THE PACKAGE THE NURSE NOTICED THE STOCKINGS WERE MOLDY. THE NURSE RETURNED TO THE SUPPLY ROOM AND NOTED ALL OF THE STOCKINGS IN THE SAME CONDITION. THE MATERIALS CHECKED THE LOT NUMBER AND REMOVED ALL ITEMS WITH THIS LOT NUMBER. UNFORTUNATELY, MATERIALS DISCARDED THE ITEMS INSTEAD OF RETURNING TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123479 CAP ANTI-EMBOLISM STOCKINGS STOCKING, MEDICAL SUPPORT (TO PREVENT POOLING OF BLOOD IN LEGS) DWL CAROLON CO. 288 16

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE KNOWN