UNKNOWN Adverse Event — Injury (MDR 3002808486-2020-00456)
UNKNOWN Adverse Event — Injury (MDR 3002808486-2020-00456) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: UNKNOWN; Generic name: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR; Manufacturer: WILLIAM COOK EUROPE.
| Device | UNKNOWN |
|---|---|
| Generic name | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR |
| Manufacturer | WILLIAM COOK EUROPE |
| Report number | 3002808486-2020-00456 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | CONSUMER |
| Narrative | INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: VENA CAVA PERFORATION, SWELLING, PHYSICAL LIMITATIONS. THE REPORTED ALLEGATIONS HAVE BEEN FURTHER INVESTIGATED BASED ON THE INFORMATION PROVIDED TO DATE. FILTER INTERACTS WITH IVC WALL, E.G. PENETRATION/PERFORATION/EMBEDMENT. THIS MAY BE EITHER SYMPTOMATIC OR ASYMPTOMATIC. POTENTIAL |
| Source | openFDA MAUDE (device adverse events) |
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