MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-01-17 for CLARITY STREP A UNK manufactured by Rac Medicals.
[417119]
Daughter tested for quick strep throat and it came back positive. Pt was given antibiotic for 10 days. Went back and still test came back positive. Culture at the lab came back negative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1037736 |
| MDR Report Key | 666080 |
| Date Received | 2006-01-17 |
| Date of Report | 2006-01-17 |
| Date Added to Maude | 2006-01-24 |
| 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 FAMILY MEMBER OR FRIEND |
| 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 | CLARITY STREP A |
| Generic Name | * |
| Product Code | GTY |
| Date Received | 2006-01-17 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 655452 |
| Manufacturer | RAC MEDICALS |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-01-17 |