BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELT ACD VASCULAR CLOSURE DEVICE

    MDR report key: 12317986 · Received August 13, 2021

    Report

    Report Number
    3009984513-2021-00017
    Event Type
    Injury
    Date Received
    August 13, 2021
    Date of Event
    August 2, 2021
    Report Date
    September 15, 2021
    Manufacturer
    VASORUM LTD.
    Product Code
    MGB
    PMA / PMN Number
    P150006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. A REVIEW OF THE LOT RECORD WAS NOT POSSIBLE AS LOT NUMBER WAS NOT PROVIDED. THIS REPORT IS THE FINAL REPORT BEING SUBMITTED BY VASORUM UNLESS OTHERWISE REQUESTED BY THE FDA. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN THE CUSTOMER COMPLAINT FILES OF VASORUM LTD FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Description of Event or Problem · 0

    EMBOLIZATION OF IMPLANT.

    Additional Manufacturer Narrative · 1

    DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. A REVIEW OF THE LOT RECORD WAS NOT POSSIBLE AS LOT NUMBER WAS NOT PROVIDED. THIS REPORT IS THE INITIAL REPORT BEING SUBMITTED BY VASORUM. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN THE CUSTOMER COMPLAINT FILES OF VASORUM LTD FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Description of Event or Problem · 1

    POSSIBLE EMBOLIZATION OF CELT ACD DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217523 CELT ACD VASCULAR CLOSURE DEVICE VASCULAR CLOSURE DEVICE MGB VASORUM LTD. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1