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INDURA Adverse Event — Injury (MDR 6000030-2008-00713)

INDURA Adverse Event — Injury (MDR 6000030-2008-00713) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: INDURA; Manufacturer: RICE CREEK MFG; Report number: 6000030-2008-00713.

DeviceINDURA
ManufacturerRICE CREEK MFG
Report number6000030-2008-00713
Event typeInjury
Product problemY
Date received2008-02-15
Report sourceHealth Professional
NarrativeIT WAS REPORTED THAT THE DISTAL PORTION OF THE CATHETER WAS REMOVED AS THE PT EXPERIENCED LOSS OF BOWEL AND BLADDER CONTROL, LOSS OF FEELING IN ONE LEG AND WAS UNABLE TO MOVE HER LEGS. IT WAS NOT REPORTED IF ANY DEVICE TROUBLESHOOTING WAS PERFORMED. THE PUMP CONTAINED DILAUDID 1MG/ML WITH A DAILY DOSE OF 0.15MG AND BUPIVICAINE 10MG/ML WITH A DAILY DOSE OF 1.5MG. THE DRUG WAS TAKEN OUT OF THE PUMP
SourceopenFDA MAUDE (device adverse events)

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