Brand Name | IMAGE MANAGEMENT SYSTEM- EVOLUTION 4K |
Type of Device | IMAGE MANAGEMENT |
Manufacturer (Section D) |
DEPUY MITEK LLC US |
325 paramount drive |
raynham MA 02767 |
|
Manufacturer (Section G) |
DEPUY MITEK LLC US |
325 paramount drive |
|
raynham MA 02767 |
|
Manufacturer Contact |
kara
ditty-bovard
|
325 paramount drive |
raynham, MA 02767
|
6013142063
|
|
MDR Report Key | 12691833 |
MDR Text Key | 278217436 |
Report Number | 1221934-2021-03116 |
Device Sequence Number | 1 |
Product Code |
LMB
|
UDI-Device Identifier | 00817613020987 |
UDI-Public | 00817613020987 |
Combination Product (y/n) | N |
Reporter Country Code | GM |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
10/13/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | EVO4K220 |
Device Catalogue Number | 242326 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
10/13/2021 |
Initial Date FDA Received | 10/25/2021 |
Supplement Dates Manufacturer Received | 01/11/2022
|
Supplement Dates FDA Received | 01/11/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |