Brand Name | MESH SOFRADIM - PARIETEX¿ 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 avenue |
north haven, CT 06473
|
2034925563
|
|
MDR Report Key | 6637296 |
MDR Text Key | 77450882 |
Report Number | 9615742-2017-05158 |
Device Sequence Number | 1 |
Product Code |
FTL
|
Combination Product (Y/N) | N |
Reporter Country Code | US |
PMA/PMN Number | K040998 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
CONSUMER,OTHER,USER FACILITY |
Reporter Occupation |
|
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
09/29/2019 |
1 Device Was Involved in the Event |
|
1 Patient Was Involved in the Event | |
Date FDA Received | 06/13/2017 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
HEALTH PROFESSIONAL
|
Device EXPIRATION Date | 10/31/2015 |
Device MODEL Number | PCO2015 |
Device Catalogue Number | PCO2015 |
Device LOT Number | PKJ08661 |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 05/15/2019 |
Was Device Evaluated By Manufacturer? |
No Answer Provided
|
Is The Device Single Use? |
Yes
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient TREATMENT DATA |
Date Received: 06/13/2017 Patient Sequence Number: 1 |
|
|