MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-25 for BRUSH manufactured by Medical Packaging Corp..
[21961623]
After ob/gyn used new brush test for annual pap smear, rptr bled (moderately-2 pads or tampons a day) for five days. She began bleeding immediately. Her ob/gyn said she would bleed "for a bit", but rptr stated five days is rather excessive for a pap smear. Rptr feels there must be a better way to assure a good pap smear speciman.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1004857 |
| MDR Report Key | 19148 |
| Date Received | 1995-01-25 |
| Date of Report | 1995-01-14 |
| Date of Event | 1994-12-21 |
| Date Added to Maude | 1995-01-26 |
| 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 |
| 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 | BRUSH |
| Product Code | GEE |
| Date Received | 1995-01-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 19071 |
| Manufacturer | MEDICAL PACKAGING CORP. |
| Manufacturer Address | CAMARILLO CA 93012 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-01-25 |