MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-09-29 for ABBOTT UNK manufactured by Abbott Labs.
[317219]
Pt has had rapid strep test 4-5 times in the past several months and they have been positive. The last 2 times, a throat culture has been done on the same day and have both been negative. Pt has been on several antbiotics with outbreak of hives. Possible false positive results on rapid strep test.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1029662 |
| MDR Report Key | 488754 |
| Date Received | 2003-09-29 |
| Date of Report | 2003-09-29 |
| Date of Event | 2003-09-01 |
| Date Added to Maude | 2003-10-16 |
| 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 |
| 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 | ABBOTT |
| Generic Name | RAPID STREP TEST |
| Product Code | GTY |
| Date Received | 2003-09-29 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 477581 |
| Manufacturer | ABBOTT LABS |
| Manufacturer Address | 100/200 ABBOTT PARK ROAD ABBOTT PARK IL 60064 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-09-29 |