FDA Adverse Event
Death
Summary report: N
BREAST IMPLANT
MDR report key: 8754194
·
Received July 1, 2019
Report
- Report Number
- MW5087740
- Event Type
- Death
- Date Received
- July 1, 2019
- Manufacturer
- ALLERGAN INC. / MCGHAN
- Product Code
- FTR
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THIS REPORT OF AN ALCL RELATED DEATH WAS REPORTED BY DR (B)(6) TO FDA ON 06/24/2019. EVENT OCCURRED IN (B)(6). INDICATION: COSMETIC. ALCL ON RIGHT SIDE. PRESENTED AS SEROMA. DATE OF PROGRESSION: (B)(6) 2005. TIME EXPOSED: 10.8 YEARS. CYTOLOGY: CD30, CD45, ALK-.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 545342 | BREAST IMPLANT | PROSTHESIS, BREAST, NON-INFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN INC. / MCGHAN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |