MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-03-21 for XOMED 2011-03 REF. 18-82040 manufactured by *.
[19954936]
Inner cannula tip broke off during procedure. The broken tip was retrieved with suction from the turbinate. No injury to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 449322 |
| MDR Report Key | 449322 |
| Date Received | 2003-03-21 |
| Date of Report | 2003-03-21 |
| Date of Event | 2003-03-19 |
| Date Facility Aware | 2003-03-21 |
| Report Date | 2003-03-21 |
| Date Reported to FDA | 2003-03-21 |
| Date Reported to Mfgr | 2003-03-21 |
| Date Added to Maude | 2003-03-25 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XOMED |
| Generic Name | INFERIOR TURBINATE BLADE, 2.0MM |
| Product Code | HQP |
| Date Received | 2003-03-21 |
| Model Number | 2011-03 |
| Catalog Number | REF. 18-82040 |
| Lot Number | 28534500 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 438307 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-03-21 |