HIRES ULTRA 3D IMPLANT Adverse Event — Injury (MDR 3006556115-2020-00320)
HIRES ULTRA 3D IMPLANT Adverse Event — Injury (MDR 3006556115-2020-00320) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: HIRES ULTRA 3D IMPLANT; Generic name: COCHLEAR IMPLANT; Manufacturer: ADVANCED BIONICS, LLC.
| Device | HIRES ULTRA 3D IMPLANT |
|---|---|
| Generic name | COCHLEAR IMPLANT |
| Manufacturer | ADVANCED BIONICS, LLC |
| Report number | 3006556115-2020-00320 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL |
| Narrative | ADDITIONAL INFORMATION: SECTIONS B.3 & D.7 THE RECIPIENT'S DEVICE WAS REPORTEDLY EXPLANTED. THE RECIPIENT WILL NOT BE REIMPLANTED AT THIS TIME. THE RECIPIENT HAS HEALED FROM SURGERY AND THE PAIN HAS RESOLVED. DISCLAIMER: ADVANCED BIONICS DOES NOT INTEND THAT THIS REPORT BE ANY ADMISSION OF LIABILITY, FAULT OR PRODUCT DEFECT. |
| Source | openFDA MAUDE (device adverse events) |
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