Brand Name | IDEAL IMPLANT STRUCTURED BREAST IMPLANT |
Type of Device | SALINE-FILLED BREAST IMPLANT |
Manufacturer (Section D) |
IDEAL IMPLANT INCORPORATED |
14881 quorum drive |
suite 925 |
dallas TX 75254 |
|
Manufacturer (Section G) |
TRELLEBORG SEALING SOLUTIONS |
343 franklin rd |
suite 108 |
brentwood TN 37027 |
|
Manufacturer Contact |
robert
hamas
|
14881 quorum drive |
suite 925 |
dallas, TX 75254
|
2144922500
|
|
MDR Report Key | 17132162 |
MDR Text Key | 317202920 |
Report Number | 3011491947-2023-00194 |
Device Sequence Number | 1 |
Product Code |
FWM
|
UDI-Device Identifier | 10851795006015 |
UDI-Public | (01)10851795006015(241)24001(17)240603 |
Combination Product (y/n) | N |
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 |
Report Date |
05/30/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/14/2023 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 24001 |
Device Catalogue Number | 240 |
Device Lot Number | 63594 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 05/30/2023 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 06/24/2021 |
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 | 39 YR |
Patient Sex | Female |