FDA Adverse Event
Injury
Summary report: N
SILTEX SALINE MAMMARY PROSTHESIS
MDR report key: 176702
·
Received July 10, 1998
Report
- Report Number
- 1645337-1998-00116
- Event Type
- Injury
- Date Received
- July 10, 1998
- Report Date
- August 21, 1997
- Manufacturer
- MENTOR
- Product Code
- FWM
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PT WAS IMPLANTED WITH A SILTEX SALINE MAMMARY PROSTHESIS ON 2/4/1995. SUBSEQUENTLY, THE PT EXPERIENCED PAIN IN HER BREAST. THE DEVICE WAS REMOVED ON 8/21/1997.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SILTEX SALINE MAMMARY PROSTHESIS Implant | MAMMARY PROSTHESIS | FWM | MENTOR | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention |