BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2532140-2008-00053

    MDR report key: 1130703 · Received August 6, 2008

    Report

    Report Number
    2532140-2008-00053
    Event Type
    Injury
    Date Received
    August 6, 2008
    Product Code
    GDW
    PMA / PMN Number
    K032701
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    CALIFORNIA PACIFIC MED CTR DID NOT RETURN THE DEVICE FOR EVAL AS OF YET. THE HOSP ALSO FILED A MEDWATCH REPORT FOR THIS EVENT. COMPLAINT ANALYSIS AND INVESTIGATION REPORT IS ATTACHED FOR THE BATCH RECORD REVIEW ONLY. AN UPDATED REPORT WILL BE PROVIDED WHEN DEVICE IS RETURNED AND EVALUATED. REVIEWED PRODUCT RELEASE AND FOUND NO DISCREPANCIES. THE PRODUCT INVOLVED WITH THIS ICR IS BEING HELD AT THE HOSP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1