UNKNOWN Adverse Event — Injury (MDR 3002808486-2020-00460)
UNKNOWN Adverse Event — Injury (MDR 3002808486-2020-00460) 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 | 3002808486-2020-00460 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | CONSUMER |
| Narrative | MANUFACTURER REF# (B)(4). CATALOG# IS UNKNOWN BUT REFERRED TO AS COOK CELECT FILTER. OCCUPATION: NON-HEALTHCARE PROFESSIONAL. SUMMARY OF INVESTIGATION FINDINGS: THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: VENA CAVA PERFORATION, MIGRATION, TILT. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT THE FILTER DID NOT PERFORM AS INT |
| Source | openFDA MAUDE (device adverse events) |
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