Brand Name | SURGIMESH XB |
Type of Device | MESH, SURGICAL, POLYMERIC |
Manufacturer (Section D) |
ASPIDE MEDICAL |
246 allee lavoisier |
la talaudiere, 42350 |
FR 42350 |
|
Manufacturer (Section G) |
ASPIDE MEDICAL |
246 allee lavoisier |
|
la talaudiere, 42350 |
FR
42350
|
|
Manufacturer Contact |
sid ahmed
tadjer
|
246 allee lavoisier |
la talaudiere, 42350
|
FR
42350
|
77531659
|
|
MDR Report Key | 6363593 |
MDR Text Key | 68515199 |
Report Number | 3006617478-2017-00001 |
Device Sequence Number | 1 |
Product Code |
FTL
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K120025 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
02/11/2016,02/23/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
No
|
Device Operator |
Physician
|
Device Expiration Date | 06/19/2020 |
Device Model Number | SURGIMESH XB |
Device Catalogue Number | TINTRAC 10 |
Device Lot Number | F12007A |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 02/11/2016 |
Date Report to Manufacturer | 04/25/2016 |
Initial Date Manufacturer Received |
01/24/2017 |
Initial Date FDA Received | 02/28/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/30/2014 |
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 |
|
|