MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-12-29 for TAXO A DISC FOR GROUP A STREP SENSITIVITY manufactured by Columbia Diagnostics.
[17908405]
Three patients are involved. The discs failed to diagnose strep infections. The patients continued to have high fevers. Tests were conducted with another product and all three patients were group a strep positive. The rptr thinks the product is defective.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1008032 |
| MDR Report Key | 29174 |
| Date Received | 1995-12-29 |
| Date of Report | 1995-12-29 |
| Date Added to Maude | 1996-01-03 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TAXO A DISC FOR GROUP A STREP SENSITIVITY |
| Generic Name | STREP SENSITIVITY DISC |
| Product Code | JTN |
| Date Received | 1995-12-29 |
| Lot Number | 1006501514 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 30188 |
| Manufacturer | COLUMBIA DIAGNOSTICS |
| Manufacturer Address | 8001 RESEARCH WAY SPRINGFIELD VA 22153 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-12-29 |