BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPSY PADS 1 X 1.25, BLUE

    MDR report key: 3653036 · Received February 6, 2014

    Report

    Report Number
    1423337-2014-00001
    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
    Distributor report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT TISSUES WERE UNDERPROCESSED WHEN USING THE FOAM BIOPSY PADS. THIS RESULTED IN A RE-BIOPSY OF A PATIENT. ALL PATIENT IDENTIFIER INFORMATION HAS BEEN REQUESTED, BUT NOT RECEIVED AS OF (B)(6) 2014. LEICA WILL SUBMIT A FOLLOW-UP REPORT IF ADDITIONAL PATIENT IDENTIFIER INFORMATION IS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76420 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