BEUDAMED
    FDA Adverse Event Other Summary report: N

    A-TRAC DISPOSABLE GRASPING INSERT 10MM 15 PER BX

    MDR report key: 955484 · Received April 18, 2007

    Report

    Report Number
    2027111-2007-00019
    Event Type
    Other
    Date Received
    April 18, 2007
    Date of Event
    February 23, 2007
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    HET
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT BEEN RETURNED TO MFR FOR EVAL. IF PRODUCT IS RETURNED EVAL WILL BE COMPLETED AND SENT TO FDA.

    Description of Event or Problem · 1

    "ARM OF PAD BROKE OFF DURING SURGERY PROCEDURE AND HAD TO BE RETRIEVED FROM PT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 A-TRAC DISPOSABLE GRASPING INSERT 10MM 15 PER BX * HET APPLIED MEDICAL RESOURCES C4100 1027245

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other