FDA Adverse Event
Injury
Summary report: N
SMOOTH LOW BLEED GEL-FILLED MAMMARY PROSTHESIS
MDR report key: 185508
·
Received August 31, 1998
Report
- Report Number
- 1645337-1998-00163
- Event Type
- Injury
- Date Received
- August 31, 1998
- Date of Event
- August 12, 1998
- Report Date
- August 26, 1998
- Manufacturer
- MENTOR
- Product Code
- FTR
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PATIENT WAS IMPLANTED WITH A SMOOTH LOW BLEED GEL-FILLED MAMMARY PROSTHESIS ON 07/22/1992. SUBSEQUENTLY, THE PATIENT EXPERIENCED A RUPTURE OF THE DEVICE AND INFLAMMATION OF THE BREAST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SMOOTH LOW BLEED GEL-FILLED MAMMARY PROSTHESIS Implant | MAMMARY PROSTHESIS | FTR | MENTOR | NA | 60363 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |