BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMBIA EVO EXCEL

    MDR report key: 14367846 · Received May 12, 2022

    Report

    Report Number
    1423253-2022-00001
    Event Type
    Injury
    Date Received
    May 12, 2022
    Date of Event
    April 20, 2022
    Report Date
    May 2, 2022
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    KPS
    PMA / PMN Number
    K200474
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SIEMENS MEDICAL SOLUTIONS USA, INC. WAS NOTIFIED OF A PATIENT INJURY THAT OCCURRED ON (B)(6) 2022. THE OPERATOR OF THE DEVICE FAILED TO FOLLOW USE INSTRUCTIONS TO REMOVE THE PATIENT FROM THE SYSTEM BEFORE RECONFIGURING THE DETECTORS. AS A RESULT, THE PATIENT'S LEG WAS CAUGHT BETWEEN THE PATIENT BED AND THE DETECTOR. THE PATIENT SUSTAINED A LACERATION TO THE LEG THAT REQUIRED STITCHES. THERE ARE NO PRODUCT DEFECTS OR FAILURES. THERE ARE NO LABELING DEFECTS. THERE WERE NO OTHER INJURIES TO ANY OTHER PERSONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2041722 SYMBIA EVO EXCEL GAMMA CAMERA KPS SIEMENS MEDICAL SOLUTIONS USA, INC. 10910500

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention