BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPSY PADS 1 X 1.25, BLUE

    MDR report key: 3624641 · Received February 6, 2014

    Report

    Report Number
    1419341-2014-00001
    Event Type
    Injury
    Date Received
    February 6, 2014
    Date of Event
    January 10, 2014
    Report Date
    January 10, 2014
    Manufacturer
    LEICA BIOSYSTEMS RICHMOND, INC.
    Product Code
    IEO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014 - THE SUPPLIER WAS CONTACTED AND ASKED IF ANY CHANGES WERE MADE TO THE FOAM BIOPSY PADS OR TO THE BLUE COLORANT. ON (B)(4) 2014 - SUPPLIER RESPONDED STATING THE FORMULATION FOR THE FOAM GRADE HAS NOT CHANGED AND MANY DIFFERENT BATCHES OF INDIVIDUAL RAW MATERIAL HAVE BEEN USED WITHOUT INCIDENT. NO CHANGE HAS BEEN MADE IN COLORANT TYPE OR SUPPLIER OVER THE PAST YEAR. NOTHING IS ADDED TO THE FOAM TO CONTROL STATIC. ON (B)(4) 2014, QA (B)(4) TESTED RETURNED PRODUCTS FROM CUSTOMER. THE PRODUCT WAS VISUALLY INSPECTED AND COMPARED TO A DIFFERENT LOT OF THE SAME PRODUCT. THE COMPARISON SHOWED ALL PADS WERE SIMILAR IN APPEARANCE. TEN PADS OF EACH LOT WERE PLACED INTO BEAKERS WITH 50MLS OF 10% NBF. PADS VISUALLY APPEARED TO BE COMPLETELY SATURATED IN BOTH BEAKERS. THE AMOUNT OF 10% NBF THAT REMAINED IN THE BEAKERS WERE EQUIVALENT. THE BIOPSY PADS DID NOT FAIL AND FUNCTIONED AS EXPECTED. THERE HAVE BEEN NO OTHER REPORTED INCIDENTS WITH THIS PRODUCT OF THIS NATURE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE TISSUES ARE UNDER PROCESSED WHEN USING THE FOAM BIOPSY PADS. THIS RESULTED IN A RE-BIOPSY OF A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77276 BIOPSY PADS 1 X 1.25, BLUE TISSUE PROCESSING EQUIPMENT IEO LEICA BIOSYSTEMS RICHMOND, INC. 3801000 5713

    Patients

    Seq Age Sex Outcome Treatment
    1 Other