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 2019-04-12 for HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR M002020852010 manufactured by Intervascular Sas.
[145768329]
It was reported that the product is available for investigation, it should be returned to intervascular for examination. A review of the complaint device history records is ongoing, results are pending. The review of post-marketing historical data indicated that no other similar 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
[145768330]
The hospital reported that during preparation for a procedure, upon opening the graft, it appeared to be a brown spot on the graft. The graft was never implanted. A replacement device was used to complete the procedure. No physician associated. No patient involvement. The date of the event is unknown.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1640201-2019-00024 |
MDR Report Key | 8510183 |
Report Source | COMPANY REPRESENTATIVE,DISTRI |
Date Received | 2019-04-12 |
Date of Report | 2019-07-26 |
Date Mfgr Received | 2019-06-28 |
Device Manufacturer Date | 2017-10-11 |
Date Added to Maude | 2019-04-12 |
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 GOLD KNITTED MICROVEL DOUBLE VELOUR |
Generic Name | VASCULAR POLYESTER GRAFT |
Product Code | MAL |
Date Received | 2019-04-12 |
Returned To Mfg | 2019-06-03 |
Model Number | M002020852010 |
Catalog Number | M002020852010 |
Lot Number | 17K11 |
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 | 2019-04-12 |