MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-05-30 for ORA-QUICK manufactured by .
[630678]
My best friend took an ora sure swab test in the local glb and he had a positive result. After much crying and suicide contemplation, he was told that the test was a false positive -confirmed by western blot blood test-. This is such a concern for he discussed with family members, friends and lover about the positive results. Why is this test allowed on the market???
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5002139 |
| MDR Report Key | 859344 |
| Date Received | 2007-05-30 |
| Date of Report | 2007-05-30 |
| Date of Event | 2007-05-17 |
| Date Added to Maude | 2007-06-11 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORA-QUICK |
| Generic Name | ORA -SURE |
| Product Code | MTL |
| Date Received | 2007-05-30 |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 845475 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2007-05-30 |