BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, DRAPE, X-RAY

    MDR report key: 8089046 · Received November 20, 2018

    Report

    Report Number
    8089046
    Event Type
    Malfunction
    Date Received
    November 20, 2018
    Date of Event
    November 9, 2018
    Report Date
    November 13, 2018
    Manufacturer
    ADVANCE MEDICAL DESIGNS, INC.
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE UNOPENED C-DRAPE HAD A LONG BLACK HAIR IN IT. THE PACKAGE WAS STILL SEALED. LUCKILY, THE SURGICAL TECHNICIAN SAW THE HAIR BEFORE SHE OPENED THE PACKAGE AND THE STERILE FIELD WAS NOT COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928367 SYSTEM, DRAPE, X-RAY KKX ADVANCE MEDICAL DESIGNS, INC. 07-CA601 80647C8150

    Patients

    Seq Age Sex Outcome Treatment
    1