Brand Name | SIENTRA SILICONE GEL-FILLED BREAST IMPLANT |
Manufacturer (Section D) |
SIENTRA, INC |
santa barbara CA |
|
Manufacturer (Section G) |
SILIMED - INDUSTRIA DE IMPLANTES LTDA |
rua figueiredo rocha |
374 - figario geral |
rio de janeiro 2124 0 |
BR
21240
|
|
Manufacturer Contact |
joann
kuhne
|
6769 hollister ave. |
suite 201 |
santa barbara, CA 93117
|
8056798879
|
|
MDR Report Key | 3735563 |
MDR Text Key | 4277665 |
Report Number | 1651189-2014-00010 |
Device Sequence Number | 1 |
Product Code |
FTR
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P070004 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
03/28/2014 |
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 | 11/01/2016 |
Device Model Number | 20646 |
Device Catalogue Number | 20646-320RB |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/25/2014 |
Initial Date FDA Received | 03/28/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/01/2011 |
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) |
Other;
|
Patient Age | 43 YR |