MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-02-26 for ARTEGRAFT BOVINE GRAFT NDC-0137 AGG25 manufactured by Johnson & Johnson.
[15037887]
Pt is a 60 y/o bm who has been on dialysis long term; had an a-v shunt placed in femoral vessel on oct, a pseudoaneurysm developed at site of anastomosis within 1 mo. Repaired and graft functioned adequately until this surgery; at time of surgery a pseudoaneurysm was noted within midportion of graft.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 72816 |
| MDR Report Key | 72816 |
| Date Received | 1997-02-26 |
| Date of Report | 1997-01-28 |
| Date of Event | 1997-01-08 |
| Date Facility Aware | 1997-01-08 |
| Report Date | 1997-01-28 |
| Date Reported to FDA | 1997-02-19 |
| Date Reported to Mfgr | 1997-02-19 |
| Date Added to Maude | 1997-03-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| 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 | ARTEGRAFT BOVINE GRAFT |
| Generic Name | * |
| Product Code | MCI |
| Date Received | 1997-02-26 |
| Model Number | NDC-0137 |
| Catalog Number | AGG25 |
| Lot Number | * |
| ID Number | * |
| Device Expiration Date | 1998-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 MO |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 72678 |
| Manufacturer | JOHNSON & JOHNSON |
| Manufacturer Address | US ROUTE 1 AARON RD N BRUNSWICK NJ 08902 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1997-02-26 |