BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATRAUMATIC FUNDUS GRASPING INSERTS

    MDR report key: 1023497 · Received March 28, 2008

    Report

    Report Number
    2027111-2008-00003
    Event Type
    Other
    Date Received
    March 28, 2008
    Date of Event
    January 22, 2008
    Report Date
    March 31, 2008
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    DXC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT BEEN RETURNED TO THE MFR FOR EVAL. WHEN PRODUCT IS RETURNED EVAL WILL BE COMPLETED, AND FINAL REPORT WILL BE SUBMITTED. LETTER WAS SENT TO HOSP ON 3/19/08 REQUESTING PRODUCT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    "LITTLE BLUE PADS KEEP FALLING OFF WHEN USING ON PTS. ONE HAS BEEN LOST AND POSSIBLY LEFT INSIDE A PT." PT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATRAUMATIC FUNDUS GRASPING INSERTS A-TRAC GRASPER INSERTS DXC APPLIED MEDICAL RESOURCES C4103 1043523

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O