BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUMARK VISION

    MDR report key: 14692864 · Received June 15, 2022

    Report

    Report Number
    1000408433-2021-00003
    Event Type
    Injury
    Date Received
    June 15, 2022
    Date of Event
    November 15, 2021
    Report Date
    December 21, 2021
    Manufacturer
    SOMATEX MEDICAL TECHNOLOGIES GMBH
    Product Code
    NEU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    PATIENT REPORTED MULTIPLE INFECTIONS LOCATED IN THE BREAST BIOPSY LOCATION. DUE TO THIS AND THE REDNESS OF THE SKIN THE PATIENT RECEIVED ANTIBIOTICS. THE BODY REJECTED THE CLIPMARKER AND THE CLPMARKER WAS REMOVED. DESPITE MULTIPLE ATTEMPTS THE CUSTOMER DID NOT FORWARD MORE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2869885 TRUMARK VISION TRUMARK VISION NEU SOMATEX MEDICAL TECHNOLOGIES GMBH UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H