MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-25 for CENTURION ECVC5125 manufactured by Centurion Medical Products.
| Report Number | 1038445-2020-00001 |
| MDR Report Key | 9749921 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-25 |
| Date Mfgr Received | 2020-01-27 |
| Device Manufacturer Date | 2019-05-30 |
| Date Added to Maude | 2020-02-25 |
| 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. KAREN KOWALCZYK |
| Manufacturer Street | 100 CENTURION WAY |
| Manufacturer City | WILLIAMSTON, MI |
| Manufacturer Country | US |
| Manufacturer Phone | 5451122 |
| Manufacturer G1 | CENTURION MEDICAL PRODUCTS |
| Manufacturer Street | 3310 MAIN STREET |
| Manufacturer City | SALISBURY, NC |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CENTURION |
| Generic Name | CVC INSERTION BUNDLE |
| Product Code | OES |
| Date Received | 2020-02-25 |
| Returned To Mfg | 2020-02-03 |
| Model Number | ECVC5125 |
| Lot Number | 2019052950 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CENTURION MEDICAL PRODUCTS |
| Manufacturer Address | 100 CENTURION WAY WILLIAMSTON, MI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-25 |