Brand Name | SIENTRA SILICONE GEL BREAST IMPLANTS |
Type of Device | SILICONE GEL BREAST IMPLANT |
Manufacturer (Section D) |
SIENTRA INC |
3333 michelson dr |
suite 650 |
irvine CA 92612 |
|
Manufacturer (Section G) |
SIENTRA INC |
3333 michelson dr |
suite 650 |
irvine CA 92612 |
|
Manufacturer Contact |
|
MDR Report Key | 18889266 |
MDR Text Key | 337483078 |
Report Number | 1651189-2024-06601 |
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 |
Consumer,Health Professional |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
03/12/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/12/2024 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 09/01/2018 |
Device Model Number | 20621-XXXMP |
Device Catalogue Number | 20621-305MP |
Was Device Available for Evaluation? |
No
|
Distributor Facility Aware Date | 02/13/2024 |
Date Manufacturer Received | 02/13/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/12/2013 |
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 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 50 YR |
Patient Sex | Female |