Brand Name | ETHILON BLU 2/0 75CM DBLE |
Type of Device | SUTURE, NONABSORBABLE, SYNTHETIC |
Manufacturer (Section D) |
ETHICON INC. |
p.o. box 151, route 22 west |
somerville 08876 0151 |
|
Manufacturer Contact |
darlene
kyle
|
p.o. box 151, route 22 west |
somerville 08876-0151
|
9082182792
|
|
MDR Report Key | 7132411 |
MDR Text Key | 95639836 |
Report Number | 2210968-2017-71865 |
Device Sequence Number | 1 |
Product Code |
GAR
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | NA |
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,Followup |
Report Date |
11/29/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/19/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 06/30/2020 |
Device Catalogue Number | EH7625E |
Device Lot Number | JC5GLDE |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/13/2018 |
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 01/13/2018 |
Date Device Manufactured | 03/01/2015 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|