Brand Name | GYNECARE TVT SECUR SYSTEM |
Type of Device | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL |
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 |
darlene
kyle
|
route 22 west po box 151 |
somerville, NJ 08876
|
9082182792
|
|
MDR Report Key | 4946307 |
MDR Text Key | 6033654 |
Report Number | 2210968-2015-09708 |
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,other |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
05/25/2017 |
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
|
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
07/17/2015 |
Initial Date FDA Received | 07/28/2015 |
Supplement Dates Manufacturer Received | Not provided Not provided Not provided
|
Supplement Dates FDA Received | 06/14/2016 05/02/2017 05/26/2017
|
Was Device Evaluated by Manufacturer? |
No
|
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 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 61 YR |