MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-08-17 for ARTIFICIAL PROSTHESIS BLOOD VESSEL CFT-454-7 manufactured by Impra, Inc..
[18203]
Seroma at arterial anastomosis a-v graft.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 26549 |
| MDR Report Key | 26549 |
| Date Received | 1995-08-17 |
| Date of Report | 1995-07-20 |
| Date of Event | 1995-06-28 |
| Date Facility Aware | 1995-06-30 |
| Report Date | 1995-07-20 |
| Date Reported to FDA | 1995-07-20 |
| Date Reported to Mfgr | 1995-07-20 |
| Date Added to Maude | 1995-10-05 |
| 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 | ARTIFICIAL PROSTHESIS BLOOD VESSEL |
| Generic Name | ARTIFICIAL BLOOD VESSEL |
| Product Code | MCI |
| Date Received | 1995-08-17 |
| Model Number | CFT-454-7 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 4 MO |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 27259 |
| Manufacturer | IMPRA, INC. |
| Manufacturer Address | PO BOX 1740 TEMPE AZ 852801740 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1995-08-17 |