FDA Adverse Event
Injury
Summary report: N
COMB, GEL-INF. MAMMARY PROSTHESIS
MDR report key: 89564
·
Received May 7, 1997
Report
- Report Number
- 6000001-1997-00529
- Event Type
- Injury
- Date Received
- May 7, 1997
- Date of Event
- March 8, 1984
- Report Date
- April 9, 1997
- Manufacturer
- AMERICAN HEYER-SCHULTE
- Product Code
- FTR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
PLAINTIFF ALLEGES VARIOUS ILLNESSES INCLUDING, BUT NOT LIMITED TO, PAIN AND SUFFERING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COMB, GEL-INF. MAMMARY PROSTHESIS Implant | BREAST IMPLANT | FTR | AMERICAN HEYER-SCHULTE | UNK | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |