FDA Adverse Event
Injury
Summary report: N
SPECTRUM CONTOUR POST-OPERATIVELY ADJUSTABLE MAMMARY PROSTHE
MDR report key: 192075
·
Received October 12, 1998
Report
- Report Number
- 1645337-1998-00198
- Event Type
- Injury
- Date Received
- October 12, 1998
- Date of Event
- June 3, 1998
- Report Date
- September 28, 1998
- Manufacturer
- MENTOR
- Product Code
- FWM
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EG
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PT WAS IMPLANTED WITH A SPECTRUM CONTOUR POST-OPERATIVE ADJUSTABLE MAMMARY PROSTHESIS ON 8/10/1996. SUBSEQUENTLY, THE PT EXPERIENCED A SEROMA. THE DEVICE WAS REMOVED ON 7/25/1998.
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 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Required Intervention |