MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-02-06 for BARD PERIPHERAL VASCULAR * manufactured by *.
[567833]
Patient went to surgery for insertion of right axilla femoral a-v graft. Developed hematoma right groin during pacu phase - returned to surgery- found implanted graft had split above the anastomosis site. Remaining graft at femoral site ranged from a few mm to approx 13 mm. Decision made to oversaw graft (and bring back to or later) with 5-0 prolene. Graft split again. Returned to or the following day for replacement of graft. Ebl: greater than 3000 cc.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1041894 |
| MDR Report Key | 813459 |
| Date Received | 2007-02-06 |
| Date of Report | 2007-02-06 |
| Date of Event | 2006-12-21 |
| Date Added to Maude | 2007-02-09 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD PERIPHERAL VASCULAR |
| Generic Name | DYNAFLO BYPASS GRAFT |
| Product Code | FIQ |
| Date Received | 2007-02-06 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 800946 |
| Manufacturer | * |
| Manufacturer Address | PO BOX 1740 TEMPE AZ 85280 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2007-02-06 |