Brand Name | PARIETEX COMPOSITE |
Type of Device | MESH, SURGICAL, POLYMERIC |
Manufacturer (Section D) |
COVIDIEN |
60 middletown avenue |
north haven CT 06473 |
|
MDR Report Key | 5418789 |
Report Number | 5418789 |
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 |
User Facility
|
Reporter Occupation |
|
Type of Report
| Initial |
Report Date |
11/19/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/09/2016 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
|
Device Model Number | N/A |
Device Catalogue Number | PCO3020 |
Device Lot Number | PJB00391 |
Other Device ID Number | 30 X 20 CM |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 11/19/2015 |
Event Location |
Hospital
|
Date Report to Manufacturer | 11/19/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No Answer Provided
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
|
|
|