BEUDAMED
    FDA Adverse Event Other Summary report: N

    5MM X 55MM, DISPOSABLE TROCAR W/SHIELDED OBTURATOR

    MDR report key: 386403 · Received April 8, 2002

    Report

    Report Number
    2027111-2002-00010
    Event Type
    Other
    Date Received
    April 8, 2002
    Date of Event
    March 4, 2002
    Report Date
    April 8, 2002
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP
    Product Code
    HET
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PORTION OF THE PLASTIC SHIELD HAD SEPARATED FROM THE C0501 DISPOSABLE TROCAR WITH SHIELDED OBTURATOR. THE PIECE WAS RETRIEVED FROM THE PT. NO PT INJURY OR COMPLICATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5MM X 55MM, DISPOSABLE TROCAR W/SHIELDED OBTURATOR DISPOSABLE TROCAR HET APPLIED MEDICAL RESOURCES CORP C0501 01C132

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other