BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYME TESTS

    MDR report key: 4080909 · Received September 7, 2014

    Report

    Report Number
    MW5038141
    Event Type
    Injury
    Date Received
    September 7, 2014
    Date of Event
    May 25, 2012
    Report Date
    September 7, 2014
    Product Code
    LSR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REJECTED BY (B)(6). (B)(6) 2014. MORE INFORMATION NEEDED CONCERNING THE DEVICE. THERE IS NO WAY TO TELL A 4 YEAR+ STORY IN 4000 CHARACTERS. I HAD NUMEROUS INFECTIONS INCLUDING SPINAL MENINGITIS, SEPTIC STAPH, MONO AND PARVO, INFLAMMATION IN BRAIN, BELLS PALSY, TEMP PARALYSIS, DAMAGE TO NECK FROM SEVERE INFLAMMATION - EVERY DISK BULGES AND STENOSIS, TRIGEMINAL NEURITIS, SEVERE MUSCLE WEAKNESS, INABILITY TO WALK, TROUBLE BREATHING, COUGHING UP BLOOD, COUGH AND DIARRHEA FOR OVER A YEAR, DRASTIC EYE SIGHT CHANGES, INCLUDED CHIARI, LOST THE ABILITY TO COMMUNICATE PROPERLY DUE TO A NEUROLOGICAL PROBLEM MADE WORSE BY SEVERE INFLAMMATION THAT DOCTORS REFUSED TO TREAT AND SUFFERED UNIMAGINABLE PAIN, BECAUSE LYME DISEASE TESTS ARE INACCURATE AND DOCTORS NOT TRAINED PROPERLY TO RECOGNIZE IT. I WAS FINALLY DIAGNOSED AND TREATED AFTER MINDING A KNOWLEDGEABLE DOCTOR AND HAVING IGENIX TESTING WHICH I HAD TO PAY FOR SINCE INSURANCE WOULD NOT. I STILL HAVE MUSCLE ISSUES, NECK ISSUES WHICH THEY SAY I NEED SURGERY FOR, EYE PROBLEMS, PAIN AND TINGLING, MEMORY AND CONFUSION ISSUES AND ARTHRITIS ALL OVER MY BODY AS WELL AS NEUROLOGICAL ISSUES THAT MIMIC EMOTIONAL PROBLEMS. I ALSO HAVE SOMETHING LIKE PTSD ABOUT DOCTORS BECAUSE THEY WERE GOING TO JUST LET ME DIE AND CALLED ME CRAZY BECAUSE I COULDN'T STOP SHAKING AND WAS HAVING TROUBLE COMMUNICATING AND BEGGING FOR HELP. I'VE NEVER HAD ANYTHING AS BAD AS THIS LYME DISEASE AND PEOPLE WHO HAVE IT NEED HELP AND TESTING THAT WILL SHOW UP AND TREATMENT. PLEASE TRAIN THE DOCTORS ABOUT LYME DISEASE TOO. I HAVE NO DOUBT I'LL NEVER BE THE SAME AGAIN. EVENT AFTER I HAD THE BASIC LYME AND ELISA THEY SAID NEGATIVE. IGENIX SAID POSITIVE BUT ACUTE EVENT THOUGH I'D ALREADY BEEN SUFFERING FOR YEARS. YOU'LL NEVER KNOW THE HORROR I'VE EXPERIENCED UNTIL YOU'VE BEEN DYING AND DENIED CARE AND CALLED CRAZY FOR 4 YEARS. I PRAY YOU NEVER WILL. PLEASE HELP US - WHO HAVE LYME DISEASE. THE TESTS ARE NO GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547313 LYME TESTS LYME TEST LSR
    547316 ELISA LYME TEST LYME TEST LSR

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Life Threatening| O| S