FDA Adverse Event
Injury
Summary report: N
HEYER-SCHULTE BREAST IMPLANT
MDR report key: 13950
·
Received June 10, 1994
Report
- Report Number
- MW1002447
- Event Type
- Injury
- Date Received
- June 10, 1994
- Manufacturer
- V. MUELLER DIV. BAXTER HEALTHCARE CORP.
- Product Code
- FTR
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
RPTR HAD THIS CO'S BREAST IMPLANTS INSERTED IN 1975. (SEE 1002445). IN 1978 SHE HAD A SQUEEZE CAPSULOTOMY. IN 4/79, SHE HAD ANOTHER CO'S IMPLANT IMPLANTED IN THE LEFT SIDE DUE TO CARCINOMA. SHE HAD FIBROCYSTIC DISEASE OF THE RIGHT BREAST IN 10/79. IN 1/80 SHE HAD THIS IMPLANT ON THE RIGHT SIDE DUE TO CARCINOMA. IN 3/80, SHE HAD METASTATIC CARCINOMA OF THE LEFT BREAST INCISION SITE. (SAME RPTR REFERRED TO IN 1002445 AND 1002446.)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEYER-SCHULTE BREAST IMPLANT Implant | FTR | V. MUELLER DIV. BAXTER HEALTHCARE CORP. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Hospitalization| L| S |