Brand Name | PARIETEX |
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 |
sharon
murphy
|
60 middletown ave |
north haven, CT 06473
|
2034925267
|
|
MDR Report Key | 7140598 |
MDR Text Key | 95581507 |
Report Number | 9615742-2017-06144 |
Device Sequence Number | 1 |
Product Code |
FTL
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
Attorney
|
Type of Report
| Initial |
Report Date |
12/16/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/21/2017 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | UNKNOWN PARIETEX |
Device Catalogue Number | UNKNOWN PARIETEX |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 11/20/2017 |
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 |
Patient Outcome(s) |
Other;
|
|
|