Brand Name | TVT SECUR 1UP |
Type of Device | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC |
Manufacturer (Section D) |
ETHICON INC. |
p.o. box 151, route 22 west |
somerville NJ 08876 0151 |
|
Manufacturer (Section G) |
ETHICON SARL-NEUCHATEL |
puits-godet 20 |
|
neuchatel |
SZ
|
|
Manufacturer Contact |
kara
ditty-bovard
|
p.o. box 151, route 22 west |
somerville, NJ 08876-0151
|
6107428552
|
|
MDR Report Key | 7059228 |
MDR Text Key | 92929210 |
Report Number | 2210968-2017-70886 |
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 |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
11/27/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/27/2017 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 06/30/2008 |
Device Catalogue Number | TVTS1 |
Device Lot Number | 2936040 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 11/27/2019 |
Date Device Manufactured | 07/11/2006 |
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) |
Life Threatening;
|
Patient Age | 51 YR |
|
|