FDA Adverse Event
Injury
Summary report: N
CUI TEXTURED SILICONE GEL FILLED BREAST IMPLANT
MDR report key: 19931743
·
Received August 7, 2024
Report
- Report Number
- 9617229-2024-18371
- Event Type
- Injury
- Date Received
- August 7, 2024
- Date of Event
- January 1, 2024
- Report Date
- August 7, 2024
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- PMA / PMN Number
- -
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THIS EMDR IS A SUPPLEMENTAL RECORD SUBMITTED AS AN INITIAL EMDR. INITIAL EMDR SUBMITTED WITH REPORT REFERENCE # 9617229-2024-17772-00 ASSOCIATED ASSESSMENT RECORD WAS ERRONEOUSLY CANCELED (Q-150135). .
Description of Event or Problem · 0
IT HAS BEEN DETERMINED THAT THE DEVICE ASSOCIATED WITH THIS COMPLAINT IS NOT PMA APPROVED. THIS RECORD IS NO LONGER REPORTABLE TO THE FDA AND WILL BE UN-REPORTED. SEE REPORT REF # 9617229-2024-17772-00 FOR INITIAL EMDR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 552483 | CUI TEXTURED SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 3075945 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Female |