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PROXIMAL CATHETER Adverse Event — Malfunction (MDR 6000030-2008-00761)

PROXIMAL CATHETER Adverse Event — Malfunction (MDR 6000030-2008-00761) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PROXIMAL CATHETER; Manufacturer: RICE CREEK MFG; Report number: 6000030-2008-00761.

DevicePROXIMAL CATHETER
ManufacturerRICE CREEK MFG
Report number6000030-2008-00761
Event typeMalfunction
Product problemY
Date received2008-02-15
Report sourceHealth Professional
NarrativeTHE HCP REPORTED THE PT PRESENTED FOR PUMP REFILL. THE ESTIMATED RESERVOIR VOLUME WAS 2ML AND THE ACTUAL RESERVOIR VOLUME WAS 20ML. THIS WAS THE FIRST REFILL SINCE THE PUMP IMPLANT. THE PT DENIED ANY RETURN OF SYMPTOMS AND STATED SHE HAD A GOOD PAIN RELIEF. A DYE STUDY WAS DONE AND SHOWED THE CATHETER WAS DISCONNECTED FROM THE PUMP. THERE HAD BEEN NO REPORT OF MOTOR STALL. SEE MFR REPORT: 21822072
SourceopenFDA MAUDE (device adverse events)

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