MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-12-12 for CYTOLOGY BRUSH * manufactured by Columbia Diagnostic, Inc..
[38803]
Brushes are too soft, therefore are not picking up enough endocervical cells to perform pap smears. Pts at all clinics where pap smears are being performed have been forced to return for re-testing due to insufficient endocervical cells. This is not the standard of care to offer pts, and it is not cost effective.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4001729 |
| MDR Report Key | 55112 |
| Date Received | 1996-12-12 |
| Date of Report | 1996-11-08 |
| Date Added to Maude | 1996-12-16 |
| 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 |
| 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 | CYTOLOGY BRUSH |
| Generic Name | CYTOLOGY BRUSH |
| Product Code | HHT |
| Date Received | 1996-12-12 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | TD70002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 55658 |
| Manufacturer | COLUMBIA DIAGNOSTIC, INC. |
| Manufacturer Address | 8001 RESEARCH WAY SPRINGFIELD VA 22153 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-12-12 |