BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIRECT DRIVE LCA

    MDR report key: 1635501 · Received March 16, 2010

    Report

    Report Number
    2027111-2010-00031
    Event Type
    Other
    Date Received
    March 16, 2010
    Date of Event
    January 7, 2010
    Report Date
    March 12, 2010
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GDO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING PRODUCT RETURN FOR EVAL. WILL FOLLOW UP WITH ADDITIONAL INFO.

    Description of Event or Problem · 1

    "SEVERAL CLIPS DISPENSED WHEN DEPLOYED. DOCTOR HAD TO FIND ADDITIONAL CLIPS AND REMOVE FROM ABDOMEN. PHYSICIAN HAD TO SPEND TIME LOCATING AND RETRIEVING ADDITIONAL CLIPS FROM ABDOMEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIRECT DRIVE LCA NONE GDO APPLIED MEDICAL RESOURCES CA090 1096174

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization