BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATRAUMATIC FUNDUS GRASPING INSERTS

    MDR report key: 860730 · Received June 4, 2007

    Report

    Report Number
    2027111-2007-00045
    Event Type
    Other
    Date Received
    June 4, 2007
    Date of Event
    May 9, 2007
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    HET
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT BEEN RETURNED TO THE MFR FOR EVAL. IF PRODUCT IS RETURNED, EVAL WILL BE COMPLETED AND FINAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    "PLASTIC PIECE BROKE DURING SURGERY."

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other