BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIOPSY NEEDLE

    MDR report key: 15180682 · Received August 7, 2022

    Report

    Report Number
    1220592-2022-00003
    Event Type
    Injury
    Date Received
    August 7, 2022
    Date of Event
    July 4, 2022
    Report Date
    August 7, 2022
    Manufacturer
    HOBBS MEDICAL, INC.
    Product Code
    GAA
    PMA / PMN Number
    K860582
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DISTRIBUTOR OBTAINED ADDITIONAL PRODUCT/LOT INFORMATION TO HOBBS AFTER THE DATE OF THE HOBBS' INITIAL 3500A REPORT THAT REVEALED THE INCIDENT DID NOT INVOLVE A HOBBS-OWNED PRODUCT.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING THE BIOPSY ON THE RIGHT LUNG (GROUND GLASS OPACITIES), NEEDLE AND FORCEPS WERE USED AND NO BLEEDING WAS FOUND. WHEN THE PROCEDURE ENDED AND THE SURGEON WAS DOING MINI BRONCHOALVEOLAR LAVAGE SAMPLING FOR THE SECOND TIME, BLEEDING WAS FOUND ON THE SECOND TIME. 600 MILLILITERS OF BLOOD LOSS WAS REPORTED. THE PATIENT IS ALIVE WITH 2 DAYS STAY IN HOSPITAL. ONE DAY FOR OBSERVATION AND ANOTHER DAY FOR CHEST X-RAY BEFORE DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302219 UNKNOWN BIOPSY NEEDLE UNKNOWN BIOPSY NEEDLE GAA HOBBS MEDICAL, INC. SD07-20-038

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H