Brand Name | IDEAL IMPLANT STRUCTURED BREAST IMPLANT |
Type of Device | SALINE-FILLED BREAST IMPLANT |
Manufacturer (Section D) |
IDEAL IMPLANT |
14881 quorum drive |
suite 925 |
dallas TX 75254 |
|
Manufacturer (Section G) |
SPECIALTY SILICONE FABRICATORS, INC. |
2761 walnut avenue |
|
tustin CA 92780 |
|
Manufacturer Contact |
stacey
brown
|
14881 quorum drive |
suite 925 |
dallas, TX 75254
|
2144922500
|
|
MDR Report Key | 6323773 |
MDR Text Key | 67383164 |
Report Number | 3011491947-2017-00006 |
Device Sequence Number | 1 |
Product Code |
FWM
|
UDI-Device Identifier | 10851795006060 |
UDI-Public | (01)10851795006060(241)40501(17)180601 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P120011 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
04/11/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/10/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 06/01/2018 |
Device Model Number | 40501 |
Device Catalogue Number | 405 |
Device Lot Number | 61193 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/03/2017 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 01/18/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/02/2015 |
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;
|