Brand Name | OPTICAL FIBER |
Type of Device | OPTICAL FIBER |
Manufacturer (Section D) |
QUANTA SYSTEM S.P.A. |
via acquedotto, 109 |
samarate, 21017 |
IT 21017 |
|
Manufacturer (Section G) |
QUANTA SYSTEM S.P.A. |
via acquedotto, 109 |
|
samarate, 21017 |
IT
21017
|
|
Manufacturer Contact |
dario
bandiera
|
via acquedotto, 109 |
samarate, varese 21017
|
IT
21017
|
|
MDR Report Key | 14166134 |
MDR Text Key | 289757280 |
Report Number | 3004378299-2022-00074 |
Device Sequence Number | 1 |
Product Code |
GEX
|
UDI-Device Identifier | 08033945938529 |
UDI-Public | 08033945938529 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K180158 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Distributor |
Reporter Occupation |
Other
|
Remedial Action |
Replace |
Type of Report
| Initial |
Report Date |
04/21/2022 |
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 Model Number | EMP-FBX272HS-C |
Device Catalogue Number | EMP-FBX272HS-C |
Device Lot Number | H215044 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
03/25/2022
|
Initial Date FDA Received | 04/21/2022 |
Was Device Evaluated by Manufacturer? |
No
|
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 |
|
|