BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTA CORPORATION

    MDR report key: 8445246 · Received March 22, 2019

    Report

    Report Number
    1420295-2019-00004
    Event Type
    Injury
    Date Received
    March 22, 2019
    Date of Event
    January 1, 2010
    Report Date
    March 22, 2019
    Product Code
    GXC
    PMA / PMN Number
    890711
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT MW 5067590 WAS DATED (B)(6) 2018 BUT REFERENCED THE EVENT DATE AS (B)(6) 2010. THE REPORT LISTED REFERENCES TO ARTICLES WRITTEN OVER THE YEARS THAT HAD THE MECTA SPECTRUM 5000Q AS THE PRIMARY MEDICAL DEVICE. THIS IS NOT MANUFACTURED BY SOMATICS. THERE WAS A MENTION OF AN ARTICLE WRITTEN IN 1999 THAT REFERRED TO A THYMATRON DGX WHICH WAS MADE BY SOMATICS. THIS REPORT DOES NOT PROVIDE ANY CONTACT INFORMATION FOR THE PATIENTS MENTIONED IN THE ARTICLES, NO INFORMATION FOR THE TREATING PHYSICIAN, FACILITY, LABORATORY RESULTS OR ANY OBJECTIVE INFORMATION. THE PRIMARY FOCUS OF THE REPORT WAS THE MECTA MEDICAL DEVICE, WHICH IS NOT MANUFACTURED BY SOMATICS. AT THE TIME OF THIS REPORT IN JANUARY 2018, THE COMPANY DETERMINED THAT THE REPORTED EVENTS IN THE MW 5067590 WERE NOT RELATED TO SOMATICS AND THERE WAS NO WAY TO FOLLOW-UP WITH ANY COMPLAINANT. THE COMPANY IS NOW SUBMITTING THIS REPORT TO THE FDA IN AN ABUNDANCE OF CAUTION AND TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT, MW 5067590 WAS SENT TO REFERENCE ARTICLES WRITTEN MANY YEARS EARLIER THAT DESCRIBED MECTA SPECTRUM UNITS, NOT MANUFACTURED BY SOMATICS. IT ALSO MENTIONED AN ARTICLE FROM 1999 ABOUT A THYMATRON DGX DEVICE MADE BY SOMATICS. THE EVENT DATE WAS LISTED AS (B)(6) 2010 BUT THE REPORT WAS DATED (B)(6) 2017. THERE WAS NO INFORMATION ABOUT ANY COMPLAINANTS, PHYSICIANS, HOSPITAL, LABORATORIES, JUST REFERENCES TO PREVIOUS ARTICLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237213 MECTA CORPORATION MECTA SPECTRUM 5000 Q AND FROM 1999 THYMATRON DGX GXC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other