BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURATIVE

    MDR report key: 12203411 · Received July 20, 2021

    Report

    Report Number
    MW5102665
    Event Type
    Malfunction
    Date Received
    July 20, 2021
    Date of Event
    July 14, 2021
    Report Date
    July 18, 2021
    Manufacturer
    CURATIVE, INC.
    Product Code
    NNK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    TOOK TEST WITH CURATIVE. NEVER RECEIVED RESULTS OR CORRESPONDENCE. THIS WAS IN (B)(6) CURATIVE REMOTE TEST SITE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094059 CURATIVE CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE NNK CURATIVE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other