MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-02-09 for FOCAL POINT * manufactured by Tripath Imaging, Inc..
[15559816]
Cervical cytology patient sample was evaluated by focal point platform in 2003. Machine indicated that the slide /smear needed no further review. The slide was re-evaluated, during a 5 year retrospective review of slides for this patient that was prompted, because a more recent slide from 2005 indicated abnormal cells. The review of the earlier slide by the patient's physician indicated abnormal cells (hsil) notification of this report was received on january 9,2006.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1062336-2006-00001 |
| MDR Report Key | 672954 |
| Report Source | 05,06 |
| Date Received | 2006-02-09 |
| Date of Report | 2006-01-09 |
| Date of Event | 2005-12-23 |
| Date Mfgr Received | 2006-01-09 |
| Date Added to Maude | 2006-02-13 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | KENNETH EDDS |
| Manufacturer Street | 4025 STIRRUP CREEK DR SUITE 400 |
| Manufacturer City | DURHAM NC 27703 |
| Manufacturer Country | US |
| Manufacturer Postal | 27703 |
| Manufacturer Phone | * |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FOCAL POINT |
| Generic Name | AUTOMATED CERVICAL CYTOLOGY SCREENER |
| Product Code | NQN |
| Date Received | 2006-02-09 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 662262 |
| Manufacturer | TRIPATH IMAGING, INC. |
| Manufacturer Address | 780 PLANTATION DR. BURLINGTON NC 27215 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-02-09 |