BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALT COIL

    MDR report key: 17682908 · Received September 1, 2023

    Report

    Report Number
    MW5145145
    Event Type
    Malfunction
    Date Received
    September 1, 2023
    Date of Event
    August 23, 2023
    Report Date
    August 28, 2023
    Manufacturer
    BALT USA, LLC.
    Product Code
    KRD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    EMBOLIZATION COIL WAS MET WITH RESISTANCE AND DID NOT FORM CORRECTLY INSIDE PATIENT. F230500941 BALT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2224538 BALT COIL DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BALT USA, LLC. F230500941

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Other