Brand Name | PCO VENTRAL PATCH 8C |
Type of Device | PARIETEX MESH |
Manufacturer (Section D) |
SOFRADIM PRODUCTION |
116 avenue du formans |
trevoux F-01 600 |
FR F-01600 |
|
Manufacturer (Section G) |
SOFRADIM PRODUCTION |
116 avenue du formans |
|
trevoux |
FR
|
|
Manufacturer Contact |
sharon
murphy, qa
|
60 middleton ave |
north haven, CT 06473
|
2034925267
|
|
MDR Report Key | 3938558 |
MDR Text Key | 20787982 |
Report Number | 9615742-2014-00096 |
Device Sequence Number | 1 |
Product Code |
OTP
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K120506 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
02/18/2014 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 09/30/2018 |
Device Catalogue Number | PCO8VP |
Device Lot Number | PNI0626 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
02/18/2014
|
Initial Date FDA Received | 03/04/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/01/2013 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|