MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-02-27 for SHEEHY POLYCEL * 1156363 manufactured by Medtronic Xomed, Inc..
[21882020]
Sheehy total ossicular prosthesis (top) found to be missing the platform portion of the prosthesis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3708346 |
| MDR Report Key | 3708346 |
| Date Received | 2014-02-27 |
| Date of Report | 2014-02-27 |
| Date of Event | 2014-02-20 |
| Report Date | 2014-02-27 |
| Date Reported to FDA | 2014-02-27 |
| Date Reported to Mfgr | 2014-03-28 |
| Date Added to Maude | 2014-03-28 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHEEHY POLYCEL |
| Generic Name | PARTIAL OSSICULAR REPLACEMENT PROSTHESIS. |
| Product Code | ETB |
| Date Received | 2014-02-27 |
| Model Number | * |
| Catalog Number | 1156363 |
| Lot Number | 0206819482 |
| ID Number | * |
| Device Availability | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED, INC. |
| Manufacturer Address | 6743 SOUTHPOINTE DRIVE NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-27 |