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 |