BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATRAUMATIC FUNDUS GRASPING INSERTS

    MDR report key: 909874 · Received September 5, 2007

    Report

    Report Number
    2027111-2007-00075
    Event Type
    Other
    Date Received
    September 5, 2007
    Date of Event
    August 28, 2007
    Report Date
    September 7, 2007
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    HET
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS NOT BEING RETURNED TO THE MANUFATURER. DOCTOR WAS UNABLE TO LOCATE INSERT IN THE PATIENT.

    Description of Event or Problem · 1

    "BLUE PIECE OF BABCOCK INSERT CAME OFF AND WAS LOST IN PATIENT." PATIENT IS FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other