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. |
655 ethicon circle |
|
cornelia GA 30531 |
|
Manufacturer Contact |
darlene
kyle
|
p.o. box 151, route 22 west |
somerville, NJ 08876-0151
|
9082182792
|
|
MDR Report Key | 7404240 |
MDR Text Key | 105251838 |
Report Number | 2210968-2018-71993 |
Device Sequence Number | 1 |
Product Code |
FTL
|
UDI-Device Identifier | 10705031047716 |
UDI-Public | 10705031047716 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K060713 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
03/21/2018 |
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 | 06/30/2019 |
Device Catalogue Number | PCDG1 |
Device Lot Number | LGG288 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/21/2018 |
Initial Date FDA Received | 04/06/2018 |
Date Device Manufactured | 07/19/2017 |
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 |
|
|