Brand Name | PERMACOL |
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 avenue |
north haven, CT 06473
|
2034915267
|
|
MDR Report Key | 6681602 |
MDR Text Key | 78913256 |
Report Number | 9615742-2017-05177 |
Device Sequence Number | 1 |
Product Code |
FTL
|
Combination Product (y/n) | N |
Reporter Country Code | SF |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
06/01/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/30/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 02/28/2021 |
Device Model Number | 5240-150 |
Device Catalogue Number | 5240-150 |
Device Lot Number | AQC0512 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 06/01/2017 |
Date Device Manufactured | 03/16/2016 |
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 |
|
|