MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-20 for ELISA TEST manufactured by .
[66426541]
Elisa test was used on family doctor's office called and stated that we didn't have lyme, that our test was negative. We became sicker and sicker. We even took our son to see an infection disease doctor who followed cdc/idsa protocol which was found flawed by (b)(6). Our son was given 30 days of iv antibiotics and his line was pulled. I told the doctor, but he's not better yet. " this id doctor stated that he would improve on his own now. Four months later, our son relapsed worse than ever. I called his id doctor who refused to see him and left him to die. He could no longer walk. He could not swallow. Just to get him, he was (b)(6) at the time. We had to give him a washcloth to suck on. We finally learned about a lyme literate doctor and this doctor said he would not desert us like the id doctor did. This doctor saved his life. Not only did our son have lyme but he also had rmse. Bartonella, and babesia. He was bedbound for over a year. He doesn't even remember how sick he was. It took over 3 yrs of treatment but he could finally walk again, get a job and go to college. I was also told that i did not have lyme. I was given 200mg of doxy for 10 days. I knew it wasn't enough and increased it on my own to 300mg following ilads protocol, not idsa protocol that is turning pts chronic. When i got to my regular doctor, he knew that the 10 days was not enough. He knew i ran a (b)(6) and asked what i needed. I told him 300mg for 30 days with refills until i could get to our lyme literate doctor. He didn't even test me. He knew that i knew what i was talking about. Now, i have been running this association for several years and many of the pts that contact us are being told their test was negative, there's no such as lyme in (b)(6), or it's all in their head. Two pts had classic bullseye rashes and were refused treatment. A bullseye rash means lyme, no if's, buts, or ands. One pt was told it was from a spider bite so it can't be lyme. How many more need to suffer before someone stands up and does something. We need a test that looks for the bacteria itself, not look for antibiotics. When the immune system is suppressed, our bodies do not make antibodies. Too many to even put on here. There is no cure for chronic lyme. We need help. We have members who cannot afford to see a lyme literate doctor and are left to die.
Patient Sequence No: 1, Text Type: D, B5
[66426542]
Elisa test was used on family doctor's office called and stated that we didn't have lyme, that our test was negative. We became sicker and sicker. We even took our son to see an infection disease doctor who followed cdc/idsa protocol which was found flawed by (b)(6). Our son was given 30 days of iv antibiotics and his line was pulled. I told the doctor, but he's not better yet. " this id doctor stated that he would improve on his own now. Four months later, our son relapsed worse than ever. I called his id doctor who refused to see him and left him to die. He could no longer walk. He could not swallow. Just to get him, he was (b)(6) at the time. We had to give him a washcloth to suck on. We finally learned about a lyme literate doctor and this doctor said he would not desert us like the id doctor did. This doctor saved his life. Not only did our son have lyme but he also had rmse. Bartonella, and babesia. He was bedbound for over a year. He doesn't even remember how sick he was. It took over 3 yrs of treatment but he could finally walk again, get a job and go to college. I was also told that i did not have lyme. I was given 200mg of doxy for 10 days. I knew it wasn't enough and increased it on my own to 300mg following ilads protocol, not idsa protocol that is turning pts chronic. When i got to my regular doctor, he knew that the 10 days was not enough. He knew i ran a (b)(6) and asked what i needed. I told him 300mg for 30 days with refills until i could get to our lyme literate doctor. He didn't even test me. He knew that i knew what i was talking about. Now, i have been running this association for several years and many of the pts that contact us are being told their test was negative, there's no such as lyme in (b)(6), or it's all in their head. Two pts had classic bullseye rashes and were refused treatment. A bullseye rash means lyme, no if's, buts, or ands. One pt was told it was from a spider bite so it can't be lyme. How many more need to suffer before someone stands up and does something. We need a test that looks for the bacteria itself, not look for antibiotics. When the immune system is suppressed, our bodies do not make antibodies. Too many to even put on here. There is no cure for chronic lyme. We need help. We have members who cannot afford to see a lyme literate doctor and are left to die.
Patient Sequence No: 2, Text Type: D, B5
[66426543]
Elisa test was used on family doctor's office called and stated that we didn't have lyme, that our test was negative. We became sicker and sicker. We even took our son to see an infection disease doctor who followed cdc/idsa protocol which was found flawed by (b)(6). Our son was given 30 days of iv antibiotics and his line was pulled. I told the doctor, but he's not better yet. " this id doctor stated that he would improve on his own now. Four months later, our son relapsed worse than ever. I called his id doctor who refused to see him and left him to die. He could no longer walk. He could not swallow. Just to get him, he was (b)(6) at the time. We had to give him a washcloth to suck on. We finally learned about a lyme literate doctor and this doctor said he would not desert us like the id doctor did. This doctor saved his life. Not only did our son have lyme but he also had rmse. Bartonella, and babesia. He was bedbound for over a year. He doesn't even remember how sick he was. It took over 3 yrs of treatment but he could finally walk again, get a job and go to college. I was also told that i did not have lyme. I was given 200mg of doxy for 10 days. I knew it wasn't enough and increased it on my own to 300mg following ilads protocol, not idsa protocol that is turning pts chronic. When i got to my regular doctor, he knew that the 10 days was not enough. He knew i ran a (b)(6) and asked what i needed. I told him 300mg for 30 days with refills until i could get to our lyme literate doctor. He didn't even test me. He knew that i knew what i was talking about. Now, i have been running this association for several years and many of the pts that contact us are being told their test was negative, there's no such as lyme in (b)(6), or it's all in their head. Two pts had classic bullseye rashes and were refused treatment. A bullseye rash means lyme, no if's, buts, or ands. One pt was told it was from a spider bite so it can't be lyme. How many more need to suffer before someone stands up and does something. We need a test that looks for the bacteria itself, not look for antibiotics. When the immune system is suppressed, our bodies do not make antibodies. Too many to even put on here. There is no cure for chronic lyme. We need help. We have members who cannot afford to see a lyme literate doctor and are left to die.
Patient Sequence No: 3, Text Type: D, B5
[66426544]
Elisa test was used on family doctor's office called and stated that we didn't have lyme, that our test was negative. We became sicker and sicker. We even took our son to see an infection disease doctor who followed cdc/idsa protocol which was found flawed by (b)(6). Our son was given 30 days of iv antibiotics and his line was pulled. I told the doctor, but he's not better yet. " this id doctor stated that he would improve on his own now. Four months later, our son relapsed worse than ever. I called his id doctor who refused to see him and left him to die. He could no longer walk. He could not swallow. Just to get him, he was (b)(6) at the time. We had to give him a washcloth to suck on. We finally learned about a lyme literate doctor and this doctor said he would not desert us like the id doctor did. This doctor saved his life. Not only did our son have lyme but he also had rmse. Bartonella, and babesia. He was bedbound for over a year. He doesn't even remember how sick he was. It took over 3 yrs of treatment but he could finally walk again, get a job and go to college. I was also told that i did not have lyme. I was given 200mg of doxy for 10 days. I knew it wasn't enough and increased it on my own to 300mg following ilads protocol, not idsa protocol that is turning pts chronic. When i got to my regular doctor, he knew that the 10 days was not enough. He knew i ran a (b)(6) and asked what i needed. I told him 300mg for 30 days with refills until i could get to our lyme literate doctor. He didn't even test me. He knew that i knew what i was talking about. Now, i have been running this association for several years and many of the pts that contact us are being told their test was negative, there's no such as lyme in (b)(6), or it's all in their head. Two pts had classic bullseye rashes and were refused treatment. A bullseye rash means lyme, no if's, buts, or ands. One pt was told it was from a spider bite so it can't be lyme. How many more need to suffer before someone stands up and does something. We need a test that looks for the bacteria itself, not look for antibiotics. When the immune system is suppressed, our bodies do not make antibodies. Too many to even put on here. There is no cure for chronic lyme. We need help. We have members who cannot afford to see a lyme literate doctor and are left to die.
Patient Sequence No: 4, Text Type: D, B5
| Report Number | MW5067599 |
| MDR Report Key | 6294285 |
| Date Received | 2017-01-20 |
| Date of Report | 2017-01-20 |
| Date of Event | 2011-04-04 |
| Date Added to Maude | 2017-02-01 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ELISA TEST |
| Generic Name | ELISA TEST |
| Product Code | JJI |
| Date Received | 2017-01-20 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-01-20 |
| 2 | 0 | 2017-01-20 | |
| 3 | 0 | 2017-01-20 | |
| 4 | 0 | 2017-01-20 |