MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-12-10 for LUSK DISPOSABLE ADENOID CURETTE 1423002 manufactured by Medtronic Xomed, Inc..
[344388]
The packaging was for the lusk disposable adenoid curette, size 2 inches. When the package was opened by the or tech, a lusk dispoable adenoid curette, size 4" was found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 560909 |
| MDR Report Key | 560909 |
| Date Received | 2004-12-10 |
| Date of Report | 2004-12-10 |
| Date of Event | 2004-08-23 |
| Report Date | 2004-12-10 |
| Date Reported to FDA | 2004-12-10 |
| Date Added to Maude | 2004-12-23 |
| 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 | LUSK DISPOSABLE ADENOID CURETTE |
| Generic Name | ADENOID CURETTE |
| Product Code | FZS |
| Date Received | 2004-12-10 |
| Returned To Mfg | 2004-08-23 |
| Model Number | 1423002 |
| Catalog Number | 1423002 |
| Lot Number | 3398700 |
| ID Number | * |
| Device Availability | N |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 550617 |
| Manufacturer | MEDTRONIC XOMED, INC. |
| Manufacturer Address | 6743 SOUTHPOINT DRIVE NORTH JACKSONVILLE FL 32216 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-12-10 |