MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-07-30 for HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR M00202175208P0 manufactured by Intervascular Sas.
[115357757]
(b)(4). Review of the complaint device history records is ongoing, results are pending. (b)(4). The complaint device has been received and will be inspected by our qa supervisor. (b)(4). 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
[115357758]
Before axillary anastomosis, the surgeon found that the graft was bent, with a different shape from what he used to see. After cutting the strange part, the surgeon still felt something was wrong. So he replaced the concerned graft with another same model graft.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1640201-2018-00018 |
| MDR Report Key | 7730552 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-07-30 |
| Date of Report | 2018-08-28 |
| Date of Event | 2018-07-11 |
| Date Mfgr Received | 2018-08-01 |
| Device Manufacturer Date | 2018-02-07 |
| Date Added to Maude | 2018-07-30 |
| 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 | 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 | 2018-07-30 |
| Returned To Mfg | 2018-07-19 |
| Model Number | M00202175208P0 |
| Catalog Number | M00202175208P0 |
| Lot Number | 18B07 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-07-30 |