MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-03-07 for JANSON-MIDDLETON RONGEUR OK405 * manufactured by Aesculap.
[44506]
During procedure described as nasal reconstruction for nasal septal defect, the tip of a rongeur broke inside the pt's nose. The piece was retrieved, and the procedure was completed without further incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1010895 |
| MDR Report Key | 74481 |
| Date Received | 1997-03-07 |
| Date of Report | 1997-02-24 |
| Date of Event | 1997-02-21 |
| Date Added to Maude | 1997-03-11 |
| 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 | JANSON-MIDDLETON RONGEUR |
| Generic Name | NASAL RONGEUR |
| Product Code | KBB |
| Date Received | 1997-03-07 |
| Model Number | OK405 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 74290 |
| Manufacturer | AESCULAP |
| Manufacturer Address | 1000 GATEWAY BLVD SO SAN FRANCISCO CA 94080 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-03-07 |