FDA Adverse Event
Injury
Summary report: N
SMOOTH SALINE MAMMARY PROSTHESIS
MDR report key: 168771
·
Received May 18, 1998
Report
- Report Number
- 1645337-1998-00018
- Event Type
- Injury
- Date Received
- May 18, 1998
- Date of Event
- October 14, 1997
- Report Date
- February 3, 1998
- Manufacturer
- MENTOR
- Product Code
- FWM
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PT WAS IMPLANTED WITH A SMOOTH SALINE MAMMARY PROSTHESIS ON 4/11/1997, SUBSEQUENTLY THE PT DEVELOPED NECROSIS OF THE TISSUE. THE DEVICE WAS REMOVED ON 11/21/1997 BECAUSE OF DAMAGE SUSTAINED DURING A CHECKUP VISIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SMOOTH SALINE MAMMARY PROSTHESIS Implant | MAMMARY PROSTHESIS | FWM | MENTOR | NA | 155261 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Required Intervention |