BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYSTO PACK

    MDR report key: 14111496 · Received April 13, 2022

    Report

    Report Number
    MW5108982
    Event Type
    Malfunction
    Date Received
    April 13, 2022
    Date of Event
    March 29, 2022
    Report Date
    April 11, 2022
    Manufacturer
    CARDINAL HEALTH /CARDINAL HEALTH 200, LLC
    Product Code
    NWU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    EYELASH WAS FOUND ON THE SPECIMEN CONTAINER IN CYSTO PACK ((B)(4)), LOT # 781021. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173505 CYSTO PACK ENDOSCOPE INTRODUCER KIT NWU CARDINAL HEALTH /CARDINAL HEALTH 200, LLC 781021

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown