FDA Adverse Event
Injury
Summary report: N
BREAST IMPLANTS
MDR report key: 2140645
·
Received June 22, 2011
Report
- Report Number
- MW5021116
- Event Type
- Injury
- Date Received
- June 22, 2011
- Date of Event
- January 13, 2011
- Report Date
- June 13, 2011
- Product Code
- FWM
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ALK NEGATIVE ALCL - ANAPLASTIC LARGE CELL LYMPHOMA. POSSIBLY RELATED TO BREAST IMPLANTS. HX OF HL - TREATED WITH MANTLE FIELD RADIATION THERAPY AND BREAST CANCER TREATED WITH SURGERY, CHEMO AND TAMOXIFEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BREAST IMPLANTS | BREAST IMPLANTS | FWM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Other |