MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-06-17 for IMPRA SHORT TAPERED 40A7-4 manufactured by Impra, Inc..
[63642]
The pt has end-stage renal disease and underwent placement of an arteriovenous fistula on 6/2/97, and also a perm-cath. On 6/3/97 it came to the attention of the hospital staff that the pt had pain, swelling, and blisters of the arm. The pt was transported to the operating room and the physician determined the symptoms might be a reaction to the graft or an infection and therefore the graft was removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 98839 |
| MDR Report Key | 98839 |
| Date Received | 1997-06-17 |
| Date of Report | 1997-06-12 |
| Date of Event | 1997-06-03 |
| Date Facility Aware | 1997-06-03 |
| Report Date | 1997-06-12 |
| Date Reported to FDA | 1997-10-12 |
| Date Added to Maude | 1997-06-19 |
| 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 |
| Generic Name | EPTFE VASCULAR GRAFT |
| Product Code | MCI |
| Date Received | 1997-06-17 |
| Model Number | SHORT TAPERED |
| Catalog Number | 40A7-4 |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 97411 |
| Manufacturer | IMPRA, INC. |
| Manufacturer Address | P O BOX 1740 TEMPE AZ 852801740 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-06-17 |