Type of Device | MESH, SURGICAL, POLYMERIC |
Manufacturer (Section D) |
ETHICON INC. |
p.o. box 151, route 22 west |
somerville NJ 08876 0151 |
|
Manufacturer (Section G) |
ETHICON INC.- J-PAC |
25 centre road |
|
somersworth NH 03878 |
|
Manufacturer Contact |
darlene
kyle
|
p.o. box 151, route 22 west |
somerville, NJ 08876-0151
|
9082182792
|
|
MDR Report Key | 7636037 |
MDR Text Key | 112282566 |
Report Number | 2210968-2018-73757 |
Device Sequence Number | 1 |
Product Code |
FTL
|
Combination Product (y/n) | N |
PMA/PMN Number | K984220 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
|
Type of Report
| Initial,Followup |
Report Date |
05/30/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/25/2018 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
|
Device Catalogue Number | PHSL |
Device Lot Number | 21073-50 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 06/27/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
|
Type of Device Usage |
Initial
|
Patient Treatment Data |
Date Received: 06/25/2018 Patient Sequence Number: 1 |
|
|