Brand Name | STYLE 410 FX RE-STERILIZABLE SIZER |
Type of Device | SIZER, MAMMARY, BREAST IMPLANT VOLUME |
Manufacturer (Section D) |
ALLERGAN (COSTA RICA) |
900 parkway global park |
zona franca |
|
CS |
|
Manufacturer (Section G) |
ALLERGAN (COSTA RICA) |
900 parkway global park |
zona franca |
|
CS
|
|
Manufacturer Contact |
suzanne
wojcik
|
301 w howard lane |
suite 100 |
austin, TX 78753
|
7372473605
|
|
MDR Report Key | 8407958 |
MDR Text Key | 138382829 |
Report Number | 9617229-2019-01608 |
Device Sequence Number | 1 |
Product Code |
MRD
|
UDI-Device Identifier | 10888628005365 |
UDI-Public | 10888628005365 |
Combination Product (y/n) | N |
PMA/PMN Number | K831566 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
03/11/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/11/2019 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 09/28/2020 |
Device Catalogue Number | MSZFX775 |
Device Lot Number | 2823883 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 02/15/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/28/2015 |
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;
|