FDA Adverse Event
Injury
Summary report: N
SILTEX LOW BLEED GEL-FILLED MAMMARY PROSTHESIS
MDR report key: 230951
·
Received July 1, 1999
Report
- Report Number
- 1645337-1999-00133
- Event Type
- Injury
- Date Received
- July 1, 1999
- Date of Event
- April 19, 1999
- Report Date
- June 15, 1999
- Manufacturer
- MENTOR
- Product Code
- FTR
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PATIENT WAS IMPLANTED WITH SILTEX LOW BLEED GEL-FILLED MAMMARY PROSTHESIS ON 03/25/1999. SUBSEQUENTLY, THE PATIENT EXPERIENCED A RUPTURE OF THE DEVICE, DELAYED WOUND HEALING AND EXTRUSION OF THE DEVICE. THE DEVICE WAS REMOVED ON 06/11/1999.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SILTEX LOW BLEED GEL-FILLED MAMMARY PROSTHESIS Implant | MAMMARY PROSTHESIS | FTR | MENTOR | NA | 170008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention |