BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 14063424 · Received April 8, 2022

    Report

    Report Number
    3012307300-2022-06042
    Event Type
    Malfunction
    Date Received
    April 8, 2022
    Report Date
    April 8, 2022
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    (4/4 REFERENCE (B)(4)) (DOCUMENTING FOURTH EVENT) PER MEDWATCH MW5107248: PATIENT REPORTED SHE HAD ISSUES WITH 4 CASSETTES OVER THE PAST MONTH. SHE KEPT THE CASSETTES BUT ONLY HAS THE LOT INFORMATION FOR TWO OF THEM: 4203283 AND 4173645. NO PATIENT INJURY. NO OTHER INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188058 CADD SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7302-24 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 Female