MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-03-02 for NUVASIVE EMG ENDOTRACHEAL TUBE 2010380 manufactured by Nuvasive.
[139049768]
No product has been returned for evaluation as product was discarded by the facility. Root cause was unable to be identified.
Patient Sequence No: 1, Text Type: N, H10
[139049769]
On (b)(6) 2019 patient underwent a total thyroidectomy procedure in which a nuvasive nv et tube was utilized. It was reported that the et tube's cuff was not holding pressure during procedure. The et tube was replaced and the issue was resolved. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031966-2019-00166 |
| MDR Report Key | 8384785 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-02 |
| Date of Report | 2019-02-19 |
| Date of Event | 2019-02-19 |
| Date Mfgr Received | 2019-02-19 |
| Date Added to Maude | 2019-03-02 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. YOBANA SANCHEZ |
| Manufacturer Street | 7475 LUSK BOULEVARD |
| Manufacturer City | SAN DIEGO 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8589093383 |
| Manufacturer G1 | NUVASIVE |
| Manufacturer Street | 7475 LUSK BOULEVARD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUVASIVE EMG ENDOTRACHEAL TUBE |
| Generic Name | NEUROSURGICAL NERVE LOCATOR |
| Product Code | PDQ |
| Date Received | 2019-03-02 |
| Model Number | 2010380 |
| Lot Number | 1812006 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUVASIVE |
| Manufacturer Address | 7475 LUSK BOULEVARD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-02 |