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 |
tracy
landers
|
5920 longbow drive |
boulder, CO 80301
|
3035816943
|
|
MDR Report Key | 11901235 |
MDR Text Key | 254585719 |
Report Number | 9615742-2021-01407 |
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 |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
05/28/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/28/2021 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 12/30/2014 |
Device Model Number | PCO12 |
Device Catalogue Number | PCO12 |
Device Lot Number | PKA00046 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 05/12/2021 |
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) |
Required Intervention;
|
Patient Age | 62 YR |