Brand Name | GYNECARE TVT ABREVO CONTINENCE SYSTEM |
Type of Device | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC |
Manufacturer (Section D) |
ETHICON INC. |
p.o. box 151, route 22 west |
somerville NJ 08876 015 |
|
Manufacturer (Section G) |
ETHICON SARL - NEUCHATEL |
puits-godet 20 2000 neuchatel |
|
neuchatel |
SZ
|
|
Manufacturer Contact |
ellen
reuss
|
route 22 west po box 151 |
somerville, NJ 08876
|
9082183095
|
|
MDR Report Key | 3606667 |
MDR Text Key | 4071091 |
Report Number | 2210968-2014-01376 |
Device Sequence Number | 1 |
Product Code |
OTN
|
Combination Product (y/n) | N |
Reporter Country Code | SW |
PMA/PMN Number | K100936 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
01/31/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/04/2014 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 09/30/2014 |
Device Catalogue Number | TVTOML |
Device Lot Number | 3732336 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 12/17/2013 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/30/2013 |
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 |
|
|