MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-27 for GRAFT FLEX SM BEAD STD 7X800MM - LOG1965364 DF8007SC manufactured by Bard Peripheral Vascular, Inc..
[185682726]
Pt had femoral tibial graft placed (b)(6) 2020. Pt had onset of groin pain. She came to er (b)(6) 2020 and was diagnosed with pseudoaneurysm due to ruptured graft. She had surgery today to repair the area. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093956 |
| MDR Report Key | 9897151 |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-18 |
| Date Added to Maude | 2020-03-30 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GRAFT FLEX SM BEAD STD 7X800MM - LOG1965364 |
| Generic Name | PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER |
| Product Code | DSY |
| Date Received | 2020-03-27 |
| Model Number | DF8007SC |
| Catalog Number | DF8007SC |
| Lot Number | VTDT0373 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Address | TEMPE AZ 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-27 |