MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-01-02 for IMPRA EXPANDED PTFE VASCULAR GRAFT UNK T4547 manufactured by Impra.
[42736]
Arteriovenous graft implanted approx 6 months ago. Began having febrile episodes within last month. Camplains of increasing pain and swelling in left arm. On exam left upper extremity with tender warm edematous forearm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 65834 |
| MDR Report Key | 65834 |
| Date Received | 1997-01-02 |
| Date of Report | 1996-10-09 |
| Date of Event | 1996-10-01 |
| Date Facility Aware | 1996-10-01 |
| Report Date | 1996-10-09 |
| Date Reported to Mfgr | 1996-10-09 |
| Date Added to Maude | 1997-02-03 |
| 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 | IMPRA EXPANDED PTFE VASCULAR GRAFT |
| Generic Name | VASCULAR GRAFT |
| Product Code | MCI |
| Date Received | 1997-01-02 |
| Model Number | UNK |
| Catalog Number | T4547 |
| Lot Number | 36444 WN |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 6 MO |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 65933 |
| Manufacturer | IMPRA |
| Manufacturer Address | PO BOX 1740 TEMPE AZ 852801740 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-01-02 |