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UNKNOWN Adverse Event — Malfunction (MDR 1820334-2020-00874)

UNKNOWN Adverse Event — Malfunction (MDR 1820334-2020-00874) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: UNKNOWN; Generic name: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR; Manufacturer: COOK INC.

DeviceUNKNOWN
Generic nameDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
ManufacturerCOOK INC
Report number1820334-2020-00874
Event typeMalfunction
Product problemY
Date received2020-04-28
Report sourceCONSUMER
NarrativeADDITIONAL INFORMATION: INVESTIGATION: THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: TILT, ANXIETY, DEPRESSION, INABILITY TO PERFORM JOB DUTIES, LOSS OF WAGES AND PHYSICAL LIMITATIONS. INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. THE REPORTED ALLEGATIONS HAVE BEEN FURTHER INVESTIGATED BASED ON THE INFORMATION PROVIDED TO DATE. FILTER TILT HAS BEEN REPORTED. POTENTIAL CAUSE
SourceopenFDA MAUDE (device adverse events)

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