Brand Name | MAYFIELD INFINITY XR2 BASE UNIT |
Type of Device | MAYFIELD |
Manufacturer (Section D) |
INTEGRA LIFESCIENCES CORPORATION OH/USA |
4900 charlemar drive |
4900 charlemar drive |
cincinnati OH |
|
Manufacturer (Section G) |
INTEGRA LIFESCIENCES CORPORATION OH/USA |
4900 charlemar drive |
|
cincinnati OH |
|
Manufacturer Contact |
vivian
nelson
|
1100 campus drive |
princeton, NJ
|
6099362319
|
|
MDR Report Key | 14240054 |
MDR Text Key | 294292231 |
Report Number | 3004608878-2022-00079 |
Device Sequence Number | 1 |
Product Code |
FWZ
|
UDI-Device Identifier | 10381780267959 |
UDI-Public | 10381780267959 |
Combination Product (y/n) | N |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
04/28/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/28/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | A2079 |
Device Catalogue Number | A2079 |
Device Lot Number | 189 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/06/2022 |
Date Manufacturer Received | 04/07/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/16/2019 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |