BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUMARK PROFESSIONAL Q FOR BREVERA STANDARD

    MDR report key: 12704897 · Received October 27, 2021

    Report

    Report Number
    1000408433-2021-00002
    Event Type
    Injury
    Date Received
    October 27, 2021
    Date of Event
    January 3, 2020
    Report Date
    October 27, 2021
    Manufacturer
    SOMATEX MEDICAL TECHNOLOGIES GMBH
    Product Code
    NEU
    UDI-DI
    04250195611321
    PMA / PMN Number
    K182082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN REPORTED INITIALLY BY A PATIENT TO THE GERMAN COMPETENT AUTHORITY. THE COMPETENT AUTHORITY FORWARDED THE INFORMATION ABOUT THE EVENT TO SOMATEX.

    Description of Event or Problem · 1

    PAIN AFTER VACUUM BIOPSY WITH CLIP MARKING. THE Q-SHAPED CLIP FROM SOMATEX STINGS AND PRESSES IN THE RIGHT BREAST TISSUE JUST UNDER THE SKIN. PAIN COMES AGAIN AND AGAIN SINCE BEGINNING OF YEAR 2020. CLIP HAS BEEN REMOVED AT (B)(6) 2021. AFTER THE PAIN STARTED IN (B)(6) 2020 THE PATIENT VISITED SEVERAL PHYSICIANS FOR EXAMINATION. DESPITE THIS, THE PAIN PERSISTED. AFTER THE CLIP WAS REMOVED THE PAIN WENT AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1603787 TUMARK PROFESSIONAL Q FOR BREVERA STANDARD TUMARK PROFESSIONAL Q FOR BREVERA STANDARD NEU SOMATEX MEDICAL TECHNOLOGIES GMBH TUMARK-BREV-S-Q 117932 04250195611321

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R