MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-05-01 for IMPRA EPTFE * manufactured by Impra, Inc..
[57221]
Graft was implanted on 2/5/97. Pt was brought back to surgery on 3/25/97 for removal of graft. The surgeon noted a serous drainage filtering through the shunt and a cheese/jelly like substance forming under the graft.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 88911 |
| MDR Report Key | 88911 |
| Date Received | 1997-05-01 |
| Date of Report | 1997-03-28 |
| Date of Event | 1997-03-25 |
| Date Facility Aware | 1997-03-25 |
| Report Date | 1997-03-28 |
| Date Reported to Mfgr | 1997-03-28 |
| Date Added to Maude | 1997-05-07 |
| 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 EPTFE |
| Generic Name | VASCULAR GRAFT |
| Product Code | MCI |
| Date Received | 1997-05-01 |
| Returned To Mfg | 1997-03-28 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | REF 40S06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 2 MO |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 87914 |
| Manufacturer | IMPRA, INC. |
| Manufacturer Address | 1628 WEST 3RD ST. TEMPE AZ 85281 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-05-01 |