MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-06-26 for CYTOBRUSH FOR CERVICAL SAMPLING NI 6515-01-279-6449 manufactured by Unimar, Inc..
[101670]
Item does not meet standard of care per the ob/gyn providers. Providers do not feel the upgraded brush causes less bleeding in their ob/gyn pts. Previous brush worked well and sufficient for their purposes. It is very difficult to use the new brush on pts who have a small cervical os. The brushes have been studied in a pilot test and have found not to have picked up enough cells during a pap smear, which results in repeat pap smears. Recommend going back to the old cytobrush plus #1101. Took new brushes off shelf and replaced with the old ones.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4002066 |
| MDR Report Key | 131967 |
| Date Received | 1997-06-26 |
| Date of Report | 1997-06-25 |
| Date Added to Maude | 1997-11-17 |
| 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 | CYTOBRUSH FOR CERVICAL SAMPLING |
| Generic Name | CYTOLOGY BRUSH |
| Product Code | HFE |
| Date Received | 1997-06-26 |
| Model Number | NI |
| Catalog Number | 6515-01-279-6449 |
| Lot Number | NI |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 129003 |
| Manufacturer | UNIMAR, INC. |
| Manufacturer Address | 475 DANBURY RD. WILTON CT 06897 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-06-26 |