BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEICA RM2255

    MDR report key: 7100546 · Received December 8, 2017

    Report

    Report Number
    1423337-2017-00020
    Event Type
    Injury
    Date Received
    December 8, 2017
    Date of Event
    October 20, 2017
    Report Date
    November 10, 2017
    Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH
    Product Code
    IDO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2017, LEICA BIOSYSTEMS WAS NOTIFIED THAT A LAB TECH INJURED (CUT) HIS FINGER DURING USAGE OF THE MICROTOME INSTRUMENT. MEDICAL TREATMENT WAS NECESSARY. ACCORDING TO THE CUSTOMER, THE INCIDENT OCCURRED ON (B)(6) 2017. AS PER THE MANUFACTURER INVESTIGATION, THE USER DISREGARDED THE INSTRUMENT SAFETY INSTRUCTIONS RESULTING IN THE INJURY. SAFETY TRAINING WAS PERFORMED WITH THE USER FOLLOWING THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879817 LEICA RM2255 MICROTOME IDO LEICA BIOSYSTEMS NUSSLOCH GMBH 1492255UL01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other