MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-12 for XPS? HANDPIECE - UNKNOWN XOM UNKNOWN DRILL manufactured by Medtronic Xomed Inc..
[90409374]
The device has not been returned. A product analysis has not been performed. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[90409375]
The customer reported that the drill overheated. The product and serial number are unknown. Requests for additional information have been made. There was no reported patient injury or impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2017-00363 |
| MDR Report Key | 6945859 |
| Date Received | 2017-10-12 |
| Date of Report | 2017-09-22 |
| Date Mfgr Received | 2017-09-22 |
| Date Added to Maude | 2017-10-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | URIZA SHUMS |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328405 |
| Manufacturer G1 | MEDTRONIC XOMED INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR N |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | XPS? HANDPIECE - UNKNOWN |
| Generic Name | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) |
| Product Code | HBG |
| Date Received | 2017-10-12 |
| Model Number | XOM UNKNOWN DRILL |
| Catalog Number | XOM UNKNOWN DRILL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR N JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-12 |