MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-10-24 for MEDTRONIC BLADE 1884016HR manufactured by Medtronic Xomed, Inc..
[17136365]
Doctor was getting ready to use the medtronic abrader with the 60 degree 4mm blade. Just before placing it in the pt? S nose, he noticed a wire sticking out. When he tested the abrader, without touching the pt, the tip broke off. The blade was removed from the sterile field and replaced with a new one. He completed the surgery without any complications. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5027378 |
| MDR Report Key | 2809439 |
| Date Received | 2012-10-24 |
| Date of Report | 2012-10-15 |
| Date of Event | 2012-09-25 |
| Date Added to Maude | 2012-11-01 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDTRONIC BLADE |
| Generic Name | RAD 60 BLADE, 4MM |
| Product Code | KTG |
| Date Received | 2012-10-24 |
| Catalog Number | 1884016HR |
| Lot Number | H8057101 |
| ID Number | REF# 1884016HR |
| Device Expiration Date | 2015-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED, INC. |
| Manufacturer Address | JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-24 |