BEUDAMED
    FDA Adverse Event Other Summary report: N

    DISPOSABLE CLIP APPLIER DIRECT DRIVE 10MM

    MDR report key: 851167 · Received May 16, 2007

    Report

    Report Number
    2027111-2007-00036
    Event Type
    Other
    Date Received
    May 16, 2007
    Date of Event
    April 26, 2007
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GDO
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT BEEN RETURNED TO THE MANUFACTURER. WHEN RETURNED PRODUCT WILL BE EVALUATED AND FINAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    "METAL FELL OFF CLIPS INTO PATIENTS ABDOMEN. CLIP WOULD NOT CLOSE AROUND DUCT. CLIPS FELL OUT." EVERYTHING WAS RETREIVED AND THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE CLIP APPLIER DIRECT DRIVE 10MM NONE GDO APPLIED MEDICAL RESOURCES CORP. CA080 135792

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other