BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATRAUMATIC FUNDUS GRASPING INSERTS

    MDR report key: 374762 · Received January 31, 2002

    Report

    Report Number
    2027111-2002-00004
    Event Type
    Other
    Date Received
    January 31, 2002
    Date of Event
    November 27, 2001
    Report Date
    January 31, 2002
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    HET
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT C4103 A-TRAC GRASPING INSERT BROKE DURING A PROCDURE. A PORTION OF THE INSERT WAS NOT RETRIEVED FROM THE PATIENT. IT WAS REPORTED THAT THE GRASPER DEVICE WAS FOUND TO BE FAULTY AND INSERTS WERE NOT SEATING CORRECTLY, COULD BE THE PROBLEM BUT NOT SURE IF THIS DEVICE WAS INVOLVED IN THE INCIDENT. NO PATIENT INJURY OR COMPLICATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATRAUMATIC FUNDUS GRASPING INSERTS A-TRAC GRASPER INSERTS HET APPLIED MEDICAL RESOURCES C4103 01J475

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other