MAUDE report
MAUDE report 15113: GORE AXILLARY POPLITEAL GRAFT
Injury · received Jan 14, 1994 · GORE AND ASSOCIATES
Key facts
| MDR report key | 15113 |
|---|---|
| Report number | 15113 |
| Event type | Injury |
| Brand name | GORE AXILLARY POPLITEAL GRAFT |
| Model number | RRT 06100100L |
| Catalog number | V-0604 |
| Manufacturer | GORE AND ASSOCIATES |
| Product code | DSY |
| Device class | Class II |
| Date received by FDA | Jan 14, 1994 |
| Report date | Dec 26, 1993 |
| Report source | Maude |
At a glance
- None Device problems coded
- 1,000+ MAUDE reports for this product code
- 1–9 MAUDE reports for this brand
- None Death reports for this brand
- 1–9 Injury reports for this brand
- No Adverse event flagged
- Yes Product problem flagged
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE medical device reports
MAUDE holds medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions submitted to the FDA by manufacturers, importers, user facilities and the public. A report alone does not establish that a device caused an event.
Source: U.S. Food and Drug Administration (FDA), MAUDE (Manufacturer and User Facility Device Experience) database · Source date: