Brand Name | GYNECARE TVT SECUR SYSTEM |
Type of Device | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC |
Manufacturer (Section D) |
ETHICON SARL |
puits-godet 20 |
neuchatel NJ 2000 |
SZ 2000 |
|
Manufacturer (Section G) |
ETHICON SARL-NEUCHATEL |
puits-godet 20 |
|
neuchatel 2000 |
SZ
2000
|
|
Manufacturer Contact |
kenneth
clark
|
route 22 westp o box 151 |
somerville, NJ 08876
|
9082183547
|
|
MDR Report Key | 5019014 |
MDR Text Key | 23613348 |
Report Number | 2210968-2015-11930 |
Device Sequence Number | 1 |
Product Code |
PAH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K052401 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
other |
Reporter Occupation |
Other
|
Type of Report
| Followup,Followup,Followup,Followup,Followup |
Report Date |
04/10/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 02/28/2011 |
Device Catalogue Number | TVTS4 |
Device Lot Number | 3289052 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 08/20/2015 |
Supplement Dates Manufacturer Received | Not provided Not provided Not provided Not provided Not provided
|
Supplement Dates FDA Received | 04/29/2016 05/25/2016 06/07/2016 09/08/2016 04/21/2017
|
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 03/25/2009 |
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 57 YR |