Brand Name | NYLON BLACK 5-0 45CM(1)SC20 |
Type of Device | SUTURE, NONABSORBABLE |
Manufacturer (Section D) |
ETHICON INC. |
p.o. box 151, route 22 west |
somerville NJ 08876 0151 |
|
Manufacturer (Section G) |
ETHICON INC.-BRAZIL |
rodovia presidente dutra |
km 154 |
sao paolo 12240 -908 |
BR
12240-908
|
|
Manufacturer Contact |
darlene
kyle
|
p.o. box 151, route 22 west |
somerville, NJ 08876-0151
|
9082182792
|
|
MDR Report Key | 8146364 |
MDR Text Key | 129794421 |
Report Number | 2210968-2018-77615 |
Device Sequence Number | 1 |
Product Code |
GAR
|
Combination Product (y/n) | N |
Reporter Country Code | BR |
PMA/PMN Number | K946173 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
11/13/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/10/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 09/30/2022 |
Device Catalogue Number | NM113X |
Device Lot Number | AJ5060 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 11/13/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/23/2017 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|