Brand Name | GYNECARE TVT DEVICE |
Type of Device | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC |
Manufacturer (Section D) |
ETHICON INC. |
p.o. box 151, route 22 west |
somerville NJ 08876 0151 |
|
MDR Report Key | 8725551 |
MDR Text Key | 148922618 |
Report Number | 2210968-2019-83132 |
Device Sequence Number | 1 |
Product Code |
OTN
|
UDI-Device Identifier | 10705031000322 |
UDI-Public | 10705031000322 |
Combination Product (y/n) | N |
PMA/PMN Number | K012628 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer,other |
Type of Report
| Initial,Followup |
Report Date |
06/06/2019 |
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 | 10/31/2016 |
Device Catalogue Number | 810041B |
Device Lot Number | 3732905 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
06/06/2019 |
Initial Date FDA Received | 06/23/2019 |
Supplement Dates Manufacturer Received | 06/21/2019
|
Supplement Dates FDA Received | 07/01/2019
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|