FDA Adverse Event
Injury
Summary report: N
STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT
MDR report key: 15392708
·
Received September 9, 2022
Report
- Report Number
- 9617229-2022-16646
- Event Type
- Injury
- Date Received
- September 9, 2022
- Report Date
- December 13, 2022
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- UDI-DI
- 05060191601467
- PMA / PMN Number
- P040046
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. 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: A2, A4, D6A.
Description of Event or Problem · 0
PHYSICIAN REPORTED RIGHT SIDE TEXTURED TO SMOOTH IMPLANT EXCHANGE. PHYSICIAN LATER REPORTED "RUPTURE" VIA RGA FORM. DEVICE HAS BEEN EXPLANTED.
Description of Event or Problem · 0
PHYSICIAN REPORTED RIGHT SIDE TEXTURED TO SMOOTH IMPLANT EXCHANGE. PHYSICIAN LATER REPORTED "RUPTURE" VIA RGA FORM. DEVICE HAS BEEN EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1139721 | STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 1731488 | 05060191601467 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |