BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3004659744-2008-00003

    MDR report key: 1003754 · Received February 8, 2008

    Report

    Report Number
    3004659744-2008-00003
    Event Type
    Injury
    Date Received
    February 8, 2008
    Product Code
    JAK
    PMA / PMN Number
    K042438
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    H6: OTHER (REFERENCE) PNEUMOTHORAX IS A KNOWN COMPLICATION WHEN A LUNG BIOPSY IS PERFORMED DURING A TRANSBRONCHIAL LUNG BIOPSY, OR CT-GUIDED PERCUTANEOUS BIOPSY WITH COMPLICATION RATES UP TO APPROX 27% WITH THE CT GUIDED PROCEDURE. BIOPSY TOOLS ARE DESIGNED TO HAVE SHARP EDGES AND THEIR FUNCTION IS TO PUNCTURE, OR OTHERWISE PENETRATE THE TISSUE IN ORDER TO COLLECT A SPECIMEN. THE PHYSICIAN STATED THAT HE BELIEVED THE PENUMOTHORAX WAS DUE TO A VIGOROUS BIOPSY HE TOOK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAK

    Patients

    Seq Age Sex Outcome Treatment
    1