BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICHOICE

    MDR report key: 7074294 · Received December 1, 2017

    Report

    Report Number
    7074294
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Date of Event
    October 29, 2017
    Report Date
    November 20, 2017
    Manufacturer
    OWENS & MINOR DISTRIBUTION, INC.
    Product Code
    KKX
    UDI-DI
    10885632101724
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A HAIR WAS FOUND INSIDE THE STERILE PACKAGE OF A DISPOSABLE OR TOWEL. THIS WAS DISCOVERED PRIOR TO THE TOWELS BEING INTRODUCED TO THE STERILE FIELD. THE CONTAMINATED PACKAGE WAS REMOVED AND REPLACED. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO PATIENT CONTAMINATION. PER SITE REPORTER: RESPONSE FROM THE MANUFACTURER IS STILL PENDING. WE WILL RETURN PACK FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855564 MEDICHOICE DRAPE, SURGICAL KKX OWENS & MINOR DISTRIBUTION, INC. ORT04B 1705GD09B 10885632101724

    Patients

    Seq Age Sex Outcome Treatment
    1