Brand Name | GUT CHR UD 27IN 5-0 S/A FS-2 |
Type of Device | SUTURE, ABSORBABLE, NATURAL |
Manufacturer (Section D) |
ETHICON INC. |
p.o. box 151, route 22 west |
somerville NJ 08876 0151 |
|
Manufacturer (Section G) |
ETHICON INC. |
avenida de las torres 7125 |
|
ciudad juarez |
MX
|
|
Manufacturer Contact |
darlene
kyle
|
p.o. box 151, route 22 west |
somerville, NJ 08876-0151
|
9082182792
|
|
MDR Report Key | 7401472 |
MDR Text Key | 104807324 |
Report Number | 2210968-2018-71958 |
Device Sequence Number | 1 |
Product Code |
GAL
|
UDI-Device Identifier | 10705031007130 |
UDI-Public | 10705031007130 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K946173 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup,Followup |
Report Date |
03/13/2018 |
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 | 08/31/2022 |
Device Catalogue Number | 634G |
Device Lot Number | LKM459 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/27/2018 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
03/13/2018 |
Initial Date FDA Received | 04/05/2018 |
Supplement Dates Manufacturer Received | 03/27/2018 04/24/2018
|
Supplement Dates FDA Received | 04/25/2018 05/07/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 09/05/2017 |
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 |