BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 7074129 · Received December 1, 2017

    Report

    Report Number
    2950347-2017-00011
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Date of Event
    June 13, 2017
    Report Date
    January 25, 2021
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K141572
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED. IT WAS REQUESTED BY FDA MEDWATCH PROGRAM DEPARTMENT ON 15-JAN-2021 TO RE-SUBMIT THIS FORM 3500A AS THERE WAS NO RECORD OF THE INITIAL REPORT SUBMISSION IN THE EMDR SYSTEM. THE INFORMATION CONTAINED IN THIS INITIAL REPORT WAS CORRECT AT THE TIME IT WAS ORIGINALLY SUBMITTED ON 19-JUL-2019.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FIELD THAT WAS TREATED WAS NOT RECORDED. BASED ON THE AVAILABLE INFORMATION THERE HAS BEEN NO ACTUAL MISTREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856786 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE IMPAC MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown