BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAC NM SYSTEM

    MDR report key: 17534973 · Received August 12, 2023

    Report

    Report Number
    MW5141873
    Event Type
    Injury
    Date Received
    August 12, 2023
    Date of Event
    September 16, 2021
    Report Date
    August 16, 2021
    Manufacturer
    PHILIPS
    Product Code
    IZJ
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS IS TO INFORM YOU THAT GE HEALTHCARE RECEIVED A SERVICE REQUEST FROM (B)(6), USA, WHERE A GE SERVICE EMPLOYEE WAS REPORTED TO HAVE A SMALL HERNIA FOLLOWING A SERVICE ACTIVITY ON AN ADAC NM SYSTEM ON (B)(6) 2021. (B)(6) WERE DISASSEMBLING TABLE END COVERS AND PEDESTAL ASSEMBLY. THE FE FELT DISCOMFORT/STRAIN WHILE REMOVING THE PEDESTAL FROM TABLE DRIVE ASSEMBLY. (B)(6) WAS OPERATED AS A MEDICAL TREATMENT FOR THE HERNIA. IT WAS CONFIRMED THAT THERE WAS NO GE HEALTHCARE SYSTEM INVOLVED THAT CAUSED OR CONTRIBUTED TO THE EVENT. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1073235 ADAC NM SYSTEM CAMERA, X-RAY, FLUOROGRAPHIC, CINE OR SPOT IZJ PHILIPS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown