MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-10-29 for PMO COMBINED PROBE CONTAINING BOTH OXYGEN AND TEMP. CC1P1 manufactured by Integra Neuroscicencs Implants Sa.
| Report Number | 9612007-2019-00042 |
| MDR Report Key | 9250602 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-10-29 |
| Date of Report | 2019-10-03 |
| Date of Event | 2019-09-23 |
| Date Mfgr Received | 2019-10-03 |
| Date Added to Maude | 2019-10-29 |
| 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 | PHYSICIAN ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. VIVIAN NELSON |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362319 |
| Manufacturer G1 | INTEGRA NEUROSCICENCS IMPLANTS SA |
| Manufacturer Street | 2905 ROUTE DES DOLINES |
| Manufacturer City | SOPHIA ANTIPOLIS F-06921 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | F-06921 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PMO COMBINED PROBE CONTAINING BOTH OXYGEN AND TEMP. |
| Generic Name | LICOX BOLTS CATHETERS & KITS |
| Product Code | GWM |
| Date Received | 2019-10-29 |
| Catalog Number | CC1P1 |
| Lot Number | 212222 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA NEUROSCICENCS IMPLANTS SA |
| Manufacturer Address | 2905 ROUTE DES DOLINES 2905 ROUTE DES DOLINES SOPHIA ANTIPOLIS F-06921 FR F-06921 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-29 |