MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-19 for SHIELDED TUNGSTEN NEUROPROBE STR-000080-10 * manufactured by Alpha Omega Co.
[5919296]
The wire would not slide in and out of the cannula. Replaced with new electrode.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4817691 |
| MDR Report Key | 4817691 |
| Date Received | 2015-05-19 |
| Date of Report | 2015-05-15 |
| Date of Event | 2015-05-15 |
| Report Date | 2015-05-15 |
| Date Reported to FDA | 2015-05-19 |
| Date Reported to Mfgr | 2015-06-04 |
| Date Added to Maude | 2015-06-04 |
| 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 | 3 |
| 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 | SHIELDED TUNGSTEN NEUROPROBE |
| Generic Name | MICROELECTRODES |
| Product Code | GZL |
| Date Received | 2015-05-19 |
| Model Number | STR-000080-10 |
| Catalog Number | * |
| Lot Number | 14552 |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALPHA OMEGA CO |
| Manufacturer Address | 5755 NORTH POINT PKWY, SUITE 2 ALPHARETTA GA 30022 US 30022 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-19 |