MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-12-14 for CYTOLOGY BURSH, DISPOSABLE CYB-18122 manufactured by Unknown.
[15448402]
Brush broke off in lung while obtaining sample. Broken brush was found and removed from pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1004422 |
| MDR Report Key | 18384 |
| Date Received | 1994-12-14 |
| Date of Report | 1994-12-05 |
| Date of Event | 1994-08-12 |
| Date Added to Maude | 1994-12-15 |
| 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 | BIOMEDICAL ENGINEER |
| 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 BURSH, DISPOSABLE |
| Product Code | GEE |
| Date Received | 1994-12-14 |
| Returned To Mfg | 1994-08-16 |
| Model Number | CYB-18122 |
| Lot Number | 93CY010 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 18312 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-12-14 |