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.
| Device | INDURA |
|---|---|
| Manufacturer | RICE CREEK MFG |
| Report number | 6000030-2008-00713 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2008-02-15 |
| Report source | Health Professional |
| Narrative | IT 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 |
| Source | openFDA MAUDE (device adverse events) |
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