BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 3252329 · Received July 10, 2013

    Report

    Report Number
    MW5031071
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 10, 2013
    Manufacturer
    CELLESTIS INC
    Product Code
    NCD
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    APPROX 3 WEEKS AGO AT (B)(6), I WAS SKIN TESTED FOR (B)(6) AND IT CAME OUT (B)(6) FOLLOWING THAT A FEW DAYS LATER, I HAD A BLOOD TEST TAKEN AND AFTER 3 WEEKS, IT CAME OUT (B)(6). AT THE SAME TIME, I WAS SCHEDULED TO TAKE AN ANNUAL PHYSICAL AT THE VA HOSPITAL IN (B)(6) AND THAT TEST WAS SENT TO (B)(6) AND CAME BACK (B)(6). THE BLOOD SAMPLES FROM (B)(6) THAT DRAW MY BLOOD USED THE REGULAR TUBES AND DID NOT USE THE MITOGEN CONTROL TUBES TO DRAW MY BLOOD BUT THE LABORATORY TECHNICIAN AT THE VA IN (B)(6) DID USE THE SPECIAL TUBES TO DRAW MY BLOOD. BECAUSE OF THE IMPACT OF LOOSING A TENTATIVE JOB AND ALSO MY HEALTH RISK AND OTHERS, REQUEST ASSISTANCE IN INVESTIGATING THE TWO MFG'S OF THE TEST CONTROL, AND THE LABORATORY RESULTS, PROCEDURES AND QUALIFICATIONS. DATES OF USE: (B)(6) 2013 - (B)(6) 2013. DIAGNOSIS OR REASON FOR USE: VERIFY (B)(6) SKIN TEST. THE (B)(6) DREW THE BLOOD AND SENT IT TO (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316325 UNK QUANTIFORM TB GOLD NCD CELLESTIS INC

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening| O CONTACT LABATORY IN (B)(6)