FDA Adverse Event
Injury
Summary report: N
SPECTRUM CONTOUR POST-OPERATIVELY ADJUSTABLE MAMMARY PROSTHE
MDR report key: 185497
·
Received August 31, 1998
Report
- Report Number
- 1645337-1998-00160
- Event Type
- Injury
- Date Received
- August 31, 1998
- Date of Event
- November 11, 1997
- Report Date
- July 7, 1998
- Manufacturer
- MENTOR
- Product Code
- FWM
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PATIENT WAS IMPLANTED WITH A SPECTRUM CONTOUR POST-OPERATIVELY ADJUSTABLE MAMMARY PROSTHESIS ON 10/21/1997. SUBSEQUENTLY, THE PATIENT EXPERIENCED A DEFLATION OF THE DEVICE AND AN INFECTION IN THE BREAST. THE DEVICE WAS REMOVED ON 01/13/1998.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPECTRUM CONTOUR POST-OPERATIVELY ADJUSTABLE MAMMARY PROSTHE Implant | MAMMARY PROSTHESIS | FWM | MENTOR | NA | 146269 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Required Intervention |