BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOPSY FORCEPS (RADIAL JAW 3)

    MDR report key: 865963 · Received June 14, 2007

    Report

    Report Number
    6000150-2007-00051
    Event Type
    Death
    Date Received
    June 14, 2007
    Report Date
    May 17, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FCL
    PMA / PMN Number
    K932265
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. A SHIP HISTORY RECORD REVIEW, AND A COMPLAINT TREND REVIEW ARE IN PROGRESS. RESULTS WILL BE PROVIDED IN A FOLLOW-UP MEDWATCH REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPSY FORCEPS (RADIAL JAW 3) FCL FCL BOSTON SCIENTIFIC M00515240 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *