Brand Name | PARIETEX COMP 3D PY 30X20CM NO THRX1 |
Type of Device | PARIETEX COMPOSITE MESH |
Manufacturer (Section D) |
SOFRADIM PRODUCTION |
116 avenue du formans |
trevoux FR F -016 |
|
Manufacturer (Section G) |
SOFRADIM PRODUCTION |
116 avenue du formans |
|
trevoux FR F -016 |
|
Manufacturer Contact |
terry
callahan
|
60 middletown ave |
north haven, CT 06473
|
2034926273
|
|
MDR Report Key | 2095034 |
MDR Text Key | 20955106 |
Report Number | 9615742-2011-00037 |
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 |
Health Professional,User facility |
Reporter Occupation |
|
Type of Report
| Initial |
Report Date |
03/23/2011 |
1 Device Was Involved in the Event |
|
1 Patient Was Involved in the Event | |
Date FDA Received | 05/09/2011 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
HEALTH PROFESSIONAL
|
Device Catalogue Number | PCO3020 |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
Yes
|
Date Manufacturer Received | 03/23/2011 |
Was Device Evaluated By Manufacturer? |
Device Not Returned To Manufacturer
|
Is The Device Single Use? |
Yes
|
Type of Device Usage |
Unkown
|