MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-04-09 for HEMASHIELD MICROVEL DOUBLE VELOUR KNITTED manufactured by Maquet Cardiovascular Llc.
[104666258]
No review of the complaint device history records and no device evaluation were performed since the product identifier could not be obtained and the involved graft was not available for investigation. No conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[104666259]
An 8mm of hemashield microvel double velour straight (unknown product details) was implanted in the patient by femoral popliteal bypass in 2004. Blood leakage was noted from the non-anastomotic area. The re-op was performed to replace the graft. It was unknown how much blood leaked. The surgery was finished with no adverse event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1640201-2018-00013 |
| MDR Report Key | 7406197 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-04-09 |
| Date of Report | 2018-04-09 |
| Date Mfgr Received | 2018-03-16 |
| Date Added to Maude | 2018-04-09 |
| 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 | 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 |
| 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 |
| Brand Name | HEMASHIELD MICROVEL DOUBLE VELOUR KNITTED |
| Generic Name | VASCULAR POLYESTER GRAFT |
| Product Code | MAL |
| Date Received | 2018-04-09 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOVASCULAR LLC |
| Manufacturer Address | 45 BARBOUR POND DRIVE WAYNE NJ 07470 US 07470 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-04-09 |