MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-17 for HYDROXYLAPATITE AND FLEX H/A/ 0590 manufactured by Medtronic Xomed.
[31797402]
During left middle ear exploration and torp revision, performed due to worsening hearing loss, the ear prosthesis was found displaced and defective. Photographic documentation was taken of the defect, and it was explanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5057969 |
| MDR Report Key | 5240054 |
| Date Received | 2015-11-17 |
| Date of Report | 2015-11-17 |
| Date of Event | 2015-11-12 |
| Date Added to Maude | 2015-11-20 |
| 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 | HYDROXYLAPATITE AND FLEX H/A/ |
| Generic Name | EAR PROSTHESIS |
| Product Code | FZD |
| Date Received | 2015-11-17 |
| Model Number | 0590 |
| Catalog Number | 0590 |
| Lot Number | 0208855737 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED |
| Manufacturer Address | JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-17 |