MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-18 for ELISA manufactured by Unk.
[65501291]
Because the tier i and tier ii lyme tests were never approved for nor meant to be a diagnostic tool, i was misdiagnosed for many years. I now have late stage lyme disease which is incurable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067365 |
| MDR Report Key | 6267447 |
| Date Received | 2017-01-18 |
| Date of Report | 2017-01-18 |
| Date of Event | 2013-07-28 |
| Date Added to Maude | 2017-01-20 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 |
| Generic Name | LYME TEST |
| Product Code | LSR |
| Date Received | 2017-01-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Brand Name | WESTERN BLOT - LYME TWO TIER TESTING SYSTEM |
| Generic Name | LYME TEST |
| Product Code | LSR |
| Date Received | 2017-01-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other; 3. Required No Informationntervention; 4. Deathisabilit | 2017-01-18 |