Brand Name | GYNECARE TVT OBTURATOR |
Type of Device | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC |
Manufacturer (Section D) |
ETHICON INC. |
p.o. box 151, route 22 west |
somerville 08876 0151 |
|
Manufacturer (Section G) |
ETHICON SARL-NEUCHATEL |
puits-godet 20 |
|
neuchatel |
SZ
|
|
Manufacturer Contact |
darlene
kyle
|
p.o. box 151, route 22 west |
somerville 08876-0151
|
9082182792
|
|
MDR Report Key | 7165840 |
MDR Text Key | 96513432 |
Report Number | 2210968-2018-70059 |
Device Sequence Number | 1 |
Product Code |
OTN
|
Combination Product (y/n) | N |
PMA/PMN Number | K033568 |
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 |
12/13/2017 |
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 | 01/31/2017 |
Device Catalogue Number | 810081 |
Device Lot Number | 3892974 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
12/13/2017
|
Initial Date FDA Received | 01/04/2018 |
Supplement Dates Manufacturer Received | 12/13/2017
|
Supplement Dates FDA Received | 06/25/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/09/2016 |
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 |
|
|