BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYPHILIS HEALTH CHECK

    MDR report key: 5284925 · Received December 9, 2015

    Report

    Report Number
    MW5058414
    Event Type
    Injury
    Date Received
    December 9, 2015
    Report Date
    December 9, 2015
    Manufacturer
    VEDALAH
    Product Code
    LIP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    1

    Narratives

    Description of Event or Problem · 1

    (B)(6) OPERATES A MOBILE OUTREACH PROGRAM IN A HIGH RISK COMMUNITY OF (B)(6). SERVICES PROVIDED INCLUDE TESTING FOR THE PRESENCE OF TREPONEMAL ANTIBODIES IN CLIENTS LACKING A HISTORY OF SYPHILIS. DURING THE PERIOD REFERENCED ABOVE 57 TESTS WERE PERFORMED WITH THE DEVICE IN QUESTION (SYPHILIS HEALTH CHECK). OF THESE 12 SPECIMENS GENERATED REACTIVE RESULTS. THESE SPECIMENS WERE SUBMITTED TO A REFERENCE LAB FOR CONFIRMATION UTILIZING RPR AND FTA. THE RESULTS WERE DISCORDANT. AS A RESULT, IT WAS DECIDED TO UTILIZE THE DEVICE IN QUESTION WITHIN TWO OF EIGHT AMBULATORY CENTERS OPERATED BY (B)(6) ON SPECIMENS TESTING. REACTIVE IN AN ON-SITE RPR AND VERIFIED FOR RPR AND FTA BY A REFERENCE LAB. IN THIS CASE, HOWEVER, THE RESULTS UTILIZING HEALTH CHECK ELICITED A NON REACTIVE RESULT. THIS OCCURRED IN THREE OF NINE SPECIMENS TESTED. DATES OF USE: 07/04/2015 - 10/21/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811056 SYPHILIS HEALTH CHECK HEALTH CHECK LIP VEDALAH NA 07015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention