BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMBIA

    MDR report key: 10509967 · Received September 9, 2020

    Report

    Report Number
    1423253-2020-00002
    Event Type
    Injury
    Date Received
    September 9, 2020
    Date of Event
    August 21, 2020
    Report Date
    August 21, 2020
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    KPS
    PMA / PMN Number
    K082506
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SIEMENS MEDICAL SOLUTIONS USA, INC. WAS NOTIFIED THROUGH THE COMPLAINT PROCESS OF A PATIENT INJURY THAT OCCURRED DURING A SPECT/CT ACQUISITION. THE SPECT PORTION OF SCAN OCCURRED WITHOUT INCIDENT. AUTOMATED MOTION WAS INITIATED BY THE OPERATOR. DURING MOTION, THE PATIENT MOVED THEIR HAND INTO THE PATIENT BED PATH OF MOTION. THE PATIENT'S LEFT HAND AND A FINGER ON THE LEFT HAND RECEIVED LACERATIONS THAT REQUIRED STITCHES. THERE ARE NO PRODUCT DEFECTS OR FAILURES. THERE ARE NO LABELING DEFECTS. THERE WERE NO INJURIES TO ANY OTHER PERSON(S).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973774 SYMBIA GAMMA CAMERA KPS SIEMENS MEDICAL SOLUTIONS USA, INC. 10275009

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention