MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2001-08-23 for MULTI-MED CENTRAL VENOUS CATHERER * manufactured by Edwards Lifesciences.
| Report Number | 6000002-2001-00328 |
| MDR Report Key | 348721 |
| Report Source | 05,06,07 |
| Date Received | 2001-08-23 |
| Date of Event | 2001-08-03 |
| Date Facility Aware | 2001-08-03 |
| Report Date | 2001-08-14 |
| Date Mfgr Received | 2001-08-08 |
| Device Manufacturer Date | 2000-11-01 |
| Date Added to Maude | 2001-08-28 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ALLISON MEZZANATTO |
| Manufacturer Street | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492502562 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTI-MED CENTRAL VENOUS CATHERER |
| Generic Name | CENTRAL VENOUS CATHETER |
| Product Code | GBP |
| Date Received | 2001-08-23 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 9 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 338040 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | ROAD 402 NORTH KM 1.0 ANASCO PR 006101576 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-08-23 |