FDA Adverse Event
Injury
Summary report: N
CUI TEXTURED SILICONE GEL FILLED BREAST IMPLANT
MDR report key: 19679492
·
Received July 5, 2024
Report
- Report Number
- 9617229-2024-16298
- Event Type
- Injury
- Date Received
- July 5, 2024
- Report Date
- October 8, 2024
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- PMA / PMN Number
- -
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: RUPTURE.
Additional Manufacturer Narrative · 0
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5; D1; D4; G4; H4
Additional Manufacturer Narrative · 0
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D1, D2, D4, G4. DEVICE INFORMATION WAS REPORTED AS: LEFT S/N: (B)(6); LOT# 2243091. RIGHT S/N: (B)(6); LOT# 2208120.
Description of Event or Problem · 0
PATIENT REPORTED AN UNKNOWN SIDE DEVICE RUPTURE. THE DEVICE HAS BEEN EXPLANTED.
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.
Description of Event or Problem · 0
PATIENT REPORTED AN UNKNOWN SIDE DEVICE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 491183 | CUI TEXTURED SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 2208120 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |