MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-25 for NEUROPROBE STR-000080-10 manufactured by Alpha Omega Company, Usa, Inc..
[58276427]
Patient Sequence No: 1, Text Type: N, H10
[58276428]
When electrode was opened to sterile field, md noted that it was not sliding through the apparatus as it should. The electrode was slightly bent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6053671 |
| MDR Report Key | 6053671 |
| Date Received | 2016-10-25 |
| Date of Report | 2016-09-30 |
| Date of Event | 2016-09-30 |
| Report Date | 2016-09-30 |
| Date Reported to FDA | 2016-09-30 |
| Date Reported to Mfgr | 2016-09-30 |
| Date Added to Maude | 2016-10-25 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUROPROBE |
| Generic Name | PROBE, NEURO |
| Product Code | GZL |
| Date Received | 2016-10-25 |
| Model Number | STR-000080-10 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALPHA OMEGA COMPANY, USA, INC. |
| Manufacturer Address | ELIZABETH CARUSO 5755 NORTH POINT PKWY. STE 229 ALPHARETTA GA 30022 US 30022 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-25 |