BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPSY PACK

    MDR report key: 6157611 · Received December 9, 2016

    Report

    Report Number
    6157611
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    October 18, 2016
    Report Date
    October 25, 2016
    Manufacturer
    AVID MEDICAL, INC. A MEDICAL ACTION IND. COMPANY AN OWENS &
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A BIOPSY KIT WAS OPENED TO DO A PROCEDURE AND WHEN THE WRAPPER WAS OPEN THERE WAS A ORANGE/ RUST COLOR STAIN ON THE TRAY AND ONE OF THE ITEMS. NOT SURE IF IT IS BETADINE OR SOME OTHER MATERIAL THAT GOT INTO THE TRAY. TECHNICIAN HAD TO RETRIEVE ANOTHER TRAY WHILE PATIENT WAS ON TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813286 BIOPSY PACK CUSTOM BIOPSY TRAY LRO AVID MEDICAL, INC. A MEDICAL ACTION IND. COMPANY AN OWENS & MTHD-010-03 1140262

    Patients

    Seq Age Sex Outcome Treatment
    1