Brand Name | VOLISTA STANDOP |
Type of Device | LAMP, SURGICAL |
Manufacturer (Section D) |
MAQUET SAS |
parc de limere |
avenue de la pomme de pin |
ardon |
|
Manufacturer (Section G) |
MAQUET SAS |
parc de limere |
avenue de la pomme de pin |
ardon |
|
Manufacturer Contact |
pascal
jay
|
parc de limere |
avenue de la pomme de pin |
ardon
|
|
MDR Report Key | 12947339 |
MDR Text Key | 282634531 |
Report Number | 9710055-2021-00369 |
Device Sequence Number | 1 |
Product Code |
FTD
|
Combination Product (y/n) | N |
Reporter Country Code | HK |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,User Facility,Company Representative |
Reporter Occupation |
|
Type of Report
| Initial,Followup,Followup |
Report Date |
02/01/2022 |
1 Device was Involved in the Event |
|
0 Patients were Involved in the Event: |
|
Date FDA Received | 12/07/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Model Number | ARD267900100A |
Device Catalogue Number | ARD267900100A |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 01/10/2022 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 10/25/2018 |
Is the Device Single Use? |
No
|
Type of Device Usage |
Reuse
|
|
|