FDA Adverse Event
Injury
Summary report: N
COMBINATION GEL-INFLATABLE MAMMARY PROSTHESIS
MDR report key: 170742
·
Received June 1, 1998
Report
- Report Number
- 6000080-1998-01120
- Event Type
- Injury
- Date Received
- June 1, 1998
- Date of Event
- July 6, 1984
- Report Date
- May 15, 1998
- Manufacturer
- AMERICAN HEYER-SCHULTE
- Product Code
- FTR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA MEDWATCH 1013671 THAT THE CONSUMER EXPERIENCED VARIOUS ILLNESSES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COMBINATION GEL-INFLATABLE MAMMARY PROSTHESIS Implant | BREAST IMPLANT | FTR | AMERICAN HEYER-SCHULTE | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |