FDA Adverse Event
Death
Summary report: N
STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT
MDR report key: 7482372
·
Received May 3, 2018
Report
- Report Number
- 9617229-2018-02867
- Event Type
- Death
- Date Received
- May 3, 2018
- Report Date
- May 3, 2018
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- PMA / PMN Number
- P040046
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
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. THE EVENT OF DEATH IS A PHYSIOLOGICAL COMPLAINT, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Description of Event or Problem · 1
HEALTH PROFESSIONAL REPORTED PATIENT "DEATH." RIGHT SIDE DEVICE REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 328144 | STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 2550604 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |