Brand Name | HLED |
Type of Device | LIGHT, SURGICAL, CEILING MOUNTED |
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 | 18650509 |
MDR Text Key | 334650561 |
Report Number | 9710055-2024-00126 |
Device Sequence Number | 1 |
Product Code |
FSY
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,User Facility,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
02/06/2024 |
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 | ARD568303903 |
Device Catalogue Number | ARD568303903 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
01/25/2024
|
Initial Date FDA Received | 02/06/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 10/13/2009 |
Is the Device Single Use? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|