FDA Adverse Event
Injury
Summary report: N
SILICONE PROSTHESIS BREAST PROSTHESIS (CLOSING SEAL WITH INFORMATION ERASED BY T
MDR report key: 16853598
·
Received May 1, 2023
Report
- Report Number
- MW5117181
- Event Type
- Injury
- Date Received
- May 1, 2023
- Date of Event
- July 21, 2022
- Report Date
- April 25, 2023
- Manufacturer
- UNK
- Product Code
- FTR
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PATIENT WITH BREAST IMPLANTS 27 YEARS AGO DEVELOPED CARCINOMA IN THE CAPSULE. REFERENCE REPORT: MW5117182.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1740056 | SILICONE PROSTHESIS BREAST PROSTHESIS (CLOSING SEAL WITH INFORMATION ERASED BY T | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Female | Other |