Brand Name | GYNECARE TVT ABREVO CONTINENCE SYSTEM |
Type of Device | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC |
Manufacturer (Section D) |
ETHICON SARL |
puits-godet 20 |
neuchatel 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 | 6487442 |
MDR Text Key | 72657062 |
Report Number | 2210968-2017-03339 |
Device Sequence Number | 1 |
Product Code |
OTN
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K100936 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
03/29/2017 |
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 | 05/31/2017 |
Device Catalogue Number | TVTOML |
Device Lot Number | 3916752 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/18/2017 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
03/29/2017
|
Initial Date FDA Received | 04/12/2017 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 05/16/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/28/2016 |
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 |