Brand Name | MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH |
Type of Device | MESH, SURGICAL, POLYMERIC |
Manufacturer (Section D) |
SOFRADIM PRODUCTION SAS |
116 avenue du formans |
trevoux 01600 |
FR 01600 |
|
Manufacturer (Section G) |
SOFRADIM PRODUCTION SAS |
116 avenue du formans |
|
trevoux 01600 |
FR
01600
|
|
Manufacturer Contact |
lisa
hernandez
|
60 middletown ave. |
north haven, CT 06473
|
2034925563
|
|
MDR Report Key | 7621528 |
MDR Text Key | 112294483 |
Report Number | 9615742-2018-01348 |
Device Sequence Number | 1 |
Product Code |
FTL
|
UDI-Device Identifier | 10884521514140 |
UDI-Public | 10884521514140 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K120506 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup,Followup |
Report Date |
10/05/2018 |
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 Expiration Date | 10/31/2022 |
Device Model Number | PCO4VP |
Device Catalogue Number | PCO4VP |
Device Lot Number | PRK1103X |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/03/2018 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/05/2018 |
Initial Date FDA Received | 06/20/2018 |
Supplement Dates Manufacturer Received | 07/03/2018 08/08/2018
|
Supplement Dates FDA Received | 08/01/2018 10/04/2018
|
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 01/10/2018 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |