MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-03-01 for HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR M00202175208P0 manufactured by Intervascular Sas.
[137578572]
Device is not accessible for testing. A review of the complaint device history records is ongoing; results are pending. Two unopened devices from same lot will be returned from the customer. They will undergo water permeability testing. The review of post-marketing historical data indicated that no other complaint was reported for the same lot number. 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
[137578573]
Following a return of unopened original packaging grafts for credit, it was reported that surgeons do not want to use this graft type anymore since the involved graft leaked/oozed blood when implanted. There was no injury to the patient but event details are unavailable (date, description, incident handling).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1640201-2019-00016 |
| MDR Report Key | 8382786 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-03-01 |
| Date of Report | 2019-04-12 |
| Date Mfgr Received | 2019-03-14 |
| Device Manufacturer Date | 2018-06-06 |
| Date Added to Maude | 2019-03-01 |
| 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 | INTERVASCULAR SAS |
| Manufacturer Street | Z.I. ATHELIA I |
| Manufacturer City | LA CIOTAT CEDEX, 13705 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 13705 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR |
| Generic Name | VASCULAR POLYESTER GRAFT |
| Product Code | MAL |
| Date Received | 2019-03-01 |
| Model Number | M00202175208P0 |
| Catalog Number | M00202175208P0 |
| Lot Number | 18F06 |
| Device Availability | N |
| 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 | 2019-03-01 |