MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-11-28 for PRESSIO ICP AND ICT MONITORING KIT, VENTRICULAR TUNNELING PSO-VTT manufactured by Sophysa.
| Report Number | 3001587388-2019-19510 |
| MDR Report Key | 9390382 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-11-28 |
| Date of Report | 2019-11-24 |
| Date of Event | 2019-10-09 |
| Date Mfgr Received | 2019-10-25 |
| Device Manufacturer Date | 2019-06-20 |
| Date Added to Maude | 2019-11-28 |
| 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 | MR PHILIPPE NEGRE |
| Manufacturer Street | 5 RUE GUY MOQUET |
| Manufacturer City | ORSAY, 91400 |
| Manufacturer Country | FR |
| Manufacturer Postal | 91400 |
| Manufacturer G1 | SOPHYSA |
| Manufacturer Street | RUE SOPHIE GERMAIN |
| Manufacturer City | BESANCON, 25000 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 25000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRESSIO ICP AND ICT MONITORING KIT, VENTRICULAR TUNNELING |
| Generic Name | ICP MONITORING CATHETER |
| Product Code | GWM |
| Date Received | 2019-11-28 |
| Returned To Mfg | 2019-11-18 |
| Model Number | PSO-VTT |
| Catalog Number | PSO-VTT |
| Lot Number | G0024 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOPHYSA |
| Manufacturer Address | 5 RUE GUY MOQUET ORSAY, 91400 FR 91400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-11-28 |