MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-01-04 for VASCULAR POLYESTER GRAFT manufactured by Intervascular Sas.
[132053134]
(b)(4). No investigation could be performed to date since there is no event description or graft identification available. Additional information is being sought. The investigation is still ongoing. A follow up report will be sent upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[132053135]
The patient's vascular graft (type unknown) had become infected and the surgeon wondered if this infection was due to a product change. Getinge was aware of this from an off-hand conversation with the hospital materials coordinator. No additional information could be retrieved to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1640201-2019-00001 |
| MDR Report Key | 8216856 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-01-04 |
| Date of Report | 2019-03-14 |
| Date Facility Aware | 2018-12-06 |
| Date Mfgr Received | 2018-12-06 |
| Date Added to Maude | 2019-01-04 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. LAURE FRAYSSE |
| Manufacturer Street | Z.I. ATHELIA I |
| Manufacturer City | LA CIOTAT CEDEX, 13705 |
| Manufacturer Country | FR |
| Manufacturer Postal | 13705 |
| Manufacturer G1 | MAQUET CARDIOVASCULAR LLC (IMPORTER) |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07470 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | VASCULAR POLYESTER GRAFT |
| Product Code | MAL |
| Date Received | 2019-01-04 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERVASCULAR SAS |
| Manufacturer Address | Z.I. ATHELIA I LA CIOTAT CEDEX, 13705 FR 13705 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-04 |