MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-01 for CYTOLOGY BRUSH 1000 manufactured by Royaline.
[9360]
Bristles/head fall off during procedures. This item was the subject of recall 11/93. Rptr's facility was not notified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1002682 |
| MDR Report Key | 14466 |
| Date Received | 1994-07-01 |
| Date of Report | 1994-06-21 |
| Date Added to Maude | 1994-07-05 |
| 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 | GEE |
| Date Received | 1994-07-01 |
| Model Number | 1000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 14460 |
| Manufacturer | ROYALINE |
| Manufacturer Address | SCOTTSDALE AZ 85260 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-07-01 |