MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1999-12-11 for ABBOTT TESTPACK RSV 2027-16 manufactured by Abbott Laboratories.
[20241019]
On or around 11/10/99, the account reported a positive testpack respiratory syncytial virus result for nasopharyngeal wash sample. The direct fluorescent antibody and culture were negative. No report of injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1451914-1999-00022 |
| MDR Report Key | 254345 |
| Report Source | 05,06 |
| Date Received | 1999-12-11 |
| Date of Report | 1999-12-08 |
| Date of Event | 1999-11-10 |
| Date Mfgr Received | 1999-11-10 |
| Device Manufacturer Date | 1999-10-01 |
| Date Added to Maude | 1999-12-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | PAUL LANDESMAN |
| Manufacturer Street | 200 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600643500 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643500 |
| Manufacturer Phone | 8479372688 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABBOTT TESTPACK RSV |
| Generic Name | EIA FOR THE RAPID DETECTION OF RSV |
| Product Code | GQG |
| Date Received | 1999-12-11 |
| Model Number | NA |
| Catalog Number | 2027-16 |
| Lot Number | 58788M100 |
| ID Number | NA |
| Device Expiration Date | 2000-05-28 |
| Operator | UNKNOWN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 246288 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | INTERSECTION U.S. 41 & 22ND ST NORTH CHICAGO IL 60064 US |
| Baseline Brand Name | TESTPACK RSV |
| Baseline Generic Name | EIA FOR THE RAPID DETECTION OF RSV |
| Baseline Model No | NA |
| Baseline Catalog No | 2027-16 |
| Baseline ID | NA |
| Baseline Device Family | TESTPACK RSV |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 10 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K874127 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-12-11 |