MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2019-11-20 for PULSION PULSIOCATH THERMODILUTION CATHETERS PV2014L16-A manufactured by Pulsion Medical Systems Se.
| Report Number | 3003263092-2019-00020 |
| MDR Report Key | 9346684 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2019-11-20 |
| Date of Report | 2019-11-20 |
| Date of Event | 2019-10-20 |
| Date Mfgr Received | 2019-10-22 |
| Device Manufacturer Date | 2018-08-01 |
| Date Added to Maude | 2019-11-20 |
| 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 | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SEVDE GUENGOER |
| Manufacturer Street | HANS-RIEDL-STRASSE 17 |
| Manufacturer City | FELDKIRCHEN 85622 |
| Manufacturer Country | GM |
| Manufacturer Postal | 85622 |
| Manufacturer Phone | 0894599140 |
| Manufacturer G1 | PULSION MEDICAL SYSTEMS SE |
| Manufacturer Street | HANS-RIEDL-STRASSE 17 |
| Manufacturer City | FELDKIRCHEN 85622 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 85622 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PULSION PULSIOCATH THERMODILUTION CATHETERS |
| Generic Name | PROBE, THERMODILUTION |
| Product Code | KRB |
| Date Received | 2019-11-20 |
| Model Number | PV2014L16-A |
| Catalog Number | PV2014L16-A |
| Lot Number | 644670 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PULSION MEDICAL SYSTEMS SE |
| Manufacturer Address | HANS-RIEDL-STRASSE 17 FELDKIRCHEN 85622 GM 85622 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-20 |