Brand Name | GYNECARE TVT OBTURATOR W LASR |
Type of Device | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC |
Manufacturer (Section D) |
ETHICON INC. |
1000 route 202 |
raritan NJ 08869 |
|
Manufacturer (Section G) |
ETHICON SARL-NEUCHATEL |
puits-godet 20 |
|
neuchatel |
SZ
|
|
Manufacturer Contact |
elba
bello
|
1000 route 202 |
raritan, NJ 08869
|
9083863534
|
|
MDR Report Key | 15831731 |
MDR Text Key | 303994949 |
Report Number | 2210968-2022-09629 |
Device Sequence Number | 1 |
Product Code |
OTN
|
UDI-Device Identifier | 10705031062306 |
UDI-Public | 10705031062306 |
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K033568 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
11/20/2022 |
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 | 10/31/2007 |
Device Model Number | 810081L |
Device Catalogue Number | 810081L |
Device Lot Number | 2972127 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
11/17/2022
|
Initial Date FDA Received | 11/20/2022 |
Supplement Dates Manufacturer Received | 12/01/2022
|
Supplement Dates FDA Received | 12/05/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/02/2006 |
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 Sex | Female |
|
|