Brand Name | PROSTHESIS - STAPES |
Type of Device | REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL |
Manufacturer (Section D) |
MEDTRONIC XOMED INC. |
6743 southpoint dr n |
jacksonville FL 32216 |
|
Manufacturer (Section G) |
MEDTRONIC XOMED INC. |
6743 southpoint dr n |
|
jacksonville FL 32216 |
|
Manufacturer Contact |
glen
belmer
|
6743 southpoint drive north |
jacksonville, FL 32216
|
6122713209
|
|
MDR Report Key | 13786183 |
MDR Text Key | 287347689 |
Report Number | 1045254-2022-00140 |
Device Sequence Number | 1 |
Product Code |
ETA
|
UDI-Device Identifier | 00721902848209 |
UDI-Public | 00721902848209 |
Combination Product (y/n) | N |
Reporter Country Code | NZ |
PMA/PMN Number | K002897 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
03/16/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/16/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 1156602 |
Device Catalogue Number | 1156602 |
Device Lot Number | 0213286447 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 02/15/2022 |
Date Device Manufactured | 05/09/2017 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|