FDA Adverse Event
Injury
Summary report: N
GEL-FILLED MAMMARY PROSTHESIS
MDR report key: 154467
·
Received March 6, 1998
Report
- Report Number
- 6000080-1998-00647
- Event Type
- Injury
- Date Received
- March 6, 1998
- Date of Event
- August 24, 1982
- Report Date
- February 19, 1998
- Manufacturer
- AMERICAN HEYER-SCHULTE
- Product Code
- FTR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
SECTION F COMPLETED BY BAXTER HEALTHCARE AS DESCRIBED IN INFO PROVIDED BY INITIAL REPORTER. H6: REC'D PER LITIGATION. BAXTER NEVER DESIGNED, MFG, OR SOLD BREAST IMPLANTS. THE AMERICAN HEYER-SCHULTE DIVISION OF AMERICAN HOSPITAL SUPPLY CORP CEASED MFR AND SELLING OF BREAST IMPLANTS IN 1984. BAXTER'S INVOLVEMENT IN BREAST IMPLANTS IS A RESULT OF ITS ACQUISITION OF AMERICAN HOSPITAL SUPPLY CORP IN 1986. F10: LABELING-REC'D PER LITIGATION.
Description of Event or Problem · 1
CLAIMANT ALLEGES "...INJURIES AS A RESULT OF...IMPLANTS CONTAINING OR CONSISTING OF SILICONE, SILICONE GEL, AND/OR AN ELASTOMER MADE OF SILICONE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GEL-FILLED MAMMARY PROSTHESIS Implant | BREAST IMPLANT | FTR | AMERICAN HEYER-SCHULTE | STYLE 6000 | 226644 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |