BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2027763

    MDR report key: 110237 · Received July 23, 1997

    Report

    Report Number
    1720496-1997-00488
    Event Type
    Injury
    Date Received
    July 23, 1997
    Date of Event
    May 16, 1997
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THIS IS NOT A REPORT EVENT PER EXEMPTION E19970005 BUT WE DID NOT HAVE ENOUGH INFO WHEN THE MDR WAS INITIALLY FILED TO DETERMINE THE REPORTABILITY. CO RECEIVED A LETTER FROM THE FACILITY ON 7/25/1997 INDICATING THAT IT WAS "PINCH-OFF".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2027763 Implant 1996 DQO BARD ACCESS SYSTEMS UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR