BEUDAMED
    FDA Adverse Event Other Summary report: N

    "GOLD THREAD"

    MDR report key: 1809639 · Received August 18, 2010

    Report

    Report Number
    3006228751-2009-00001
    Event Type
    Other
    Date Received
    August 18, 2010
    Report Date
    May 8, 2009
    Product Code
    GAO
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH REPORT MW5011051 WAS NOT SENT TO GOLD THREAD LLC (THE COMPANY) BUT WAS DISCOVERED BY THE COMPANY DURING ROUTINE POST-MARKET SURVEILLANCE IN NOVEMBER 2009. THE COMPANY REQUESTED AN FOI REPORT AND IT WAS RECEIVED ON DECEMBER 2, 2009. CONTACT INFO ON THE REPORT PROVED TO BE FALSE (NO SUCH ADDRESS AND THE PHONE NUMBER IS NOT WORKING - ALWAYS BUSY). AN ONLINE SERVICE WAS USED TO IDENTIFY THE OWNER OF THE PHONE NUMBER BUT WHEN CONTACTED THE OWNER COMPANY STATED THAT THE NUMBER WAS NOT ON THEIR SYSTEM AND THAT THEY HAD NO EMPLOYEE OR PERSON AT THE COMPANY BY THE NAME OF "VOLKOV". THE PRODUCT WAS NOT RETURNED. THE REPORTER DID NOT PROVIDE ANY INFO REGARDING THE PROCEDURE, THE ADVERSE EVENT, THE NATURE OF THE INJURY, THE LOT NUMBER, OR DATE OF MANUFACTURE. THE EXPIRATION DATE WAS REPORTED AS "10-FEB-2006" BUT THIS PREDATES PRODUCTS MANUFACTURED BY THE COMPANY. NO LOT NUMBER WAS REPORTED YET, THE EXPIRATION DATE WAS REPORTED. THE REPORTER CLAIMS TO BE AN ATTORNEY BUT GRAMMAR USED IN THE EVENT DESCRIPTION IMPLIES THAT THE REPORTER HAS A POOR COMMAND OF THE ENGLISH LANGUAGE WHICH WOULD BE UNUSUAL FOR AN ATTORNEY. THE COMPANY CAN DRAW NO CONCLUSION REGARDING THE ADVERSE EVENT BUT SUSPECTS THAT IT IS A MALICIOUS HOAX.

    Description of Event or Problem · 1

    MEDWATCH VOLUNTARY REPORT NO: MW5011051 (INFO FROM THIS REPORT IS SHOWN IN QUOTATION MARKS): "ADVERSE EVENT" AND "PRODUCT PROBLEM". "VOLUN (B)(6) 2009: I HAD DONE A PROCEDURE BY M.D. WITH THE GOLD THREAD... THEY DESCRIBED THAT THEY HAD THEIR APPROVAL BY THE FDA! THEY REPORTED ON THEIR SITE THAT THEY DON'T DO PROCEDURE IN THE US. PLEASE INVESTIGATE!"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 "GOLD THREAD" "GOLD THREAD" GAO NO INFO PROVIDED NO INFO PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1