BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PVA FOAM EMBOLIZATION PARTICLES

    MDR report key: 8167550 · Received December 15, 2018

    Report

    Report Number
    1820334-2018-03742
    Event Type
    Malfunction
    Date Received
    December 15, 2018
    Date of Event
    February 19, 2016
    Report Date
    December 15, 2018
    Manufacturer
    COOK INC
    Product Code
    KRD
    UDI-DI
    00827002096646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON NAME: NAJ, AGENTS, EMBOLIC, FOR TREATMENT OF UTERINE FIBROIDS. PRODUCT CODE: NAJ. THIS MDR IS BEING FILED AFTER THE ASSOCIATED COMPLAINT WAS REVIEWED UNDER REMEDIATION PROTOCOL (B)(4), COMPLAINT/MDR RETROSPECTIVE REVIEW AND REMEDIATION AND REASSESSED AS REPORTABLE. ADDITIONAL COMPLAINT INVESTIGATION AND RECORD REMEDIATION WAS NOT PERFORMED.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT THE PVA FOAM EMBOLIZATION PARTICLES TURNED RED WHILE "TURNING ON THE VIAL". PART OF THE PRODUCT(S) HAD BEEN USED ON THE PATIENT FOR THE TACE (TRANSCATHETER ARTERIAL EMBOLIZATION) PROCEDURE IN THE LIVER. THE CAUSE FOR THE RED PARTICLES COULD NOT BE DETERMINED WITH CERTAINTY, AND THIS PRODUCT PROBLEM DID NOT RESULT IN ANY REPORTED SERIOUS INJURIES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006728 PVA FOAM EMBOLIZATION PARTICLES KRD COOK INC NA 5570489 00827002096646

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR