MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-20 for WESTERN BLOT manufactured by Unk.
[89973590]
Test failed me. The 2 tier western blot does not work. I have lyme even though this test failed me, now i'm suffering with chronic lyme. This needs to stop and we need a more accurate testing like igenex. I have been misdiagnosed for years and in the end (b)(6) in testing, later it was lyme.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072863 |
| MDR Report Key | 6964629 |
| Date Received | 2017-10-20 |
| Date of Report | 2017-10-18 |
| Date Added to Maude | 2017-10-20 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | WESTERN BLOT |
| Generic Name | REAGENT, BORRELIA SEROLOGICAL REAGENT |
| Product Code | LSR |
| Date Received | 2017-10-20 |
| Lot Number | 22222 |
| ID Number | 22222 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2017-10-20 |