MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-26 for XOMED HYDROXYLAPATITE AND FLEX H/A 0590 manufactured by Medtronic.
[29944034]
During middle ear exploration, performed due to persistent conductive hearing loss in the right ear, a displaced prosthesis was located. The prosthesis was sitting in the middle ear cavity. It was removed, and it was discovered that the prosthesis had a displaced inner cannula.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5057501 |
| MDR Report Key | 5187432 |
| Date Received | 2015-10-26 |
| Date of Report | 2015-10-26 |
| Date of Event | 2015-07-09 |
| Date Added to Maude | 2015-10-29 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | XOMED HYDROXYLAPATITE AND FLEX H/A |
| Generic Name | OSSICULAR PROSTHESIS |
| Product Code | ETA |
| Date Received | 2015-10-26 |
| Model Number | 0590 |
| Catalog Number | 0590 |
| Lot Number | 0205324387 |
| Device Expiration Date | 2019-08-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC |
| Manufacturer Address | MINNEAPOLIS MN 55432 US 55432 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-26 |