BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORGON MEDICAL/MAXXIM MEDICAL

    MDR report key: 488817 · Received October 8, 2003

    Report

    Report Number
    488817
    Event Type
    Malfunction
    Date Received
    October 8, 2003
    Date of Event
    September 29, 2003
    Report Date
    October 7, 2003
    Manufacturer
    *
    Product Code
    FYA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE, A FEW SMALL HOLES WERE NOTICED ON SURGEON'S SLEEVE AROUND WRIST. SURGEON WAS GIVEN A STERILE SLEEVE. BOVIE CHECKED OUT "OK". NO USER ERROR. NO PATIENT INJURY. FABRIC IS SUSPECTED SECOND SUCH EVENT TODAY. DIFFERENT BOVIES. DIFFERENT SURGEONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORGON MEDICAL/MAXXIM MEDICAL SURGEON'S GOWN FROM LAP PACK FYA * UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other