BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAMP COVERS

    MDR report key: 3952158 · Received June 18, 2014

    Report

    Report Number
    1836161-2014-00036
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    April 30, 2014
    Report Date
    June 13, 2014
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS PRODUCT, CLAMP COVER, SAYS IT IS RADIOPAQUE. A SURGICAL HEALTHCARE WORKER NOTED NO RADIOPAQUE MATERIAL VISIBLE AND INITIATED X-RAY WITH RAYTEC. UNABLE TO IDENTIFY CLAMP COVER ON X-RAY. IT IS A COUNTABLE ITEM IN OUR SURGICAL COUNT. THIS IS POTENTIALLY DANGEROUS. DIAGNOSIS OR REASON FOR USE: SURGICAL USE: INSTRUMENT COVER TO PROTECT TISSUE FROM TRAUMA. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358452 CLAMP COVERS CLAMP COVERS KKX ASPEN SURGICAL PRODUCTS, INC. 071002PBX 32314

    Patients

    Seq Age Sex Outcome Treatment
    1