BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1420295-2019-00001

    MDR report key: 8429639 · Received March 18, 2019

    Report

    Report Number
    1420295-2019-00001
    Event Type
    Injury
    Date Received
    March 18, 2019
    Date of Event
    November 17, 2018
    Report Date
    March 18, 2019
    PMA / PMN Number
    945120
    Removal / Correction Number
    MW5081540
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASICALLY, THERE WAS NO SUPPORTIVE INFORMATION OF ANY KIND TO THE CLAIM. THE DEVICE LISTED WAS NOT A PRODUCT OF SOMATICS. THE COMPLAINANT DID NOT RESPOND TO QUESTIONS SENT AND DELIVERED TO THE SUBMITTED ADDRESS. [MW5081540].

    Description of Event or Problem · 1

    ON (B)(6) 2019 THERE WAS AN ANONYMOUS REPORT FILLED TO THE MEDWATCH MAUDE SECTION. IT CLAIMED MANY ADVERSE EVENTS PRODUCED OVER A LONG PERIOD OF TIME. IT REFERENCED MECTA CORPORATION AND THE MECTA DEVICE AS THE MANUFACTURE, BUT IT ALSO LISTED SOMATICS ON THE REPORT, EVEN THOUGH THE SOMATICS MEDICAL DEVICE WAS NOT LISTED. SEE THE MAUDE REPORT DATED (B)(6) 2018 FOR MORE DETAILS.

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFORMATION PROVIDED