FDA Adverse Event
Injury
Summary report: N
SMOOTH SALINE MAMMARY PROSTHESES
MDR report key: 182562
·
Received August 10, 1998
Report
- Report Number
- 1645337-1998-00148
- Event Type
- Injury
- Date Received
- August 10, 1998
- Date of Event
- May 19, 1998
- Report Date
- July 28, 1998
- Manufacturer
- MENTOR
- Product Code
- FWM
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PT WAS BILATERALY IMPLANTED WITH SMOOTH SALINE MAMMARY PROSTHESES ON 10/11/1996, SUBSEQUENTLY, THE PT EXPERIENCED A DEFLATION OF EACH DEVICE, PAIN AND WRINKLING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SMOOTH SALINE MAMMARY PROSTHESES Implant | MAMMARY PROSTHESIS | FWM | MENTOR | NA | 142512/135719 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Required Intervention |