MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-25 for RED CROSS TESTING CHAGAS DISEASE TEST manufactured by Unk.
[51014491]
Went to donate blood w/(b)(6). Told i was deferred until 2289 forchagus disease. Found that i had a false positive and could never donate again with no appeal process.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5063780 |
| MDR Report Key | 5840021 |
| Date Received | 2016-07-25 |
| Date of Report | 2016-07-25 |
| Date of Event | 2016-07-25 |
| Date Added to Maude | 2016-08-02 |
| 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 | RED CROSS TESTING CHAGAS DISEASE TEST |
| Generic Name | RED CROSS TESTING CHAGAS DISEASE TEST |
| Product Code | OHQ |
| Date Received | 2016-07-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-07-25 |