FDA Adverse Event
Summary report: N
HEYER-SCHULTE GEL OVAL BREAST IMPLANT
MDR report key: 10633
·
Received December 22, 1993
Report
- Report Number
- MW1000202
- Date Received
- December 22, 1993
- Manufacturer
- V. MUELLER DIV. BAXTER HEALTHCARE CORP.
- Product Code
- FTR
- Report Source
- Voluntary report
- Reporter Location
- WV, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
IMPLANTS WERE IMPLANTED ON 4/29/82. IMPLANTS BECAME HARD AND DID NOT FEEL OR APPEAR NORMAL. IMPLANTS MOVED UNDER ARM AND UP TO COLLAR BONE, BRONCHITIS, PNEUMONIA, COPD, ASTHMA, FATIGUE, SHORTNESS OF BREATH, UPPER RESPIRATORY INFECTIONS AND NERVOUSNESS. (SAME RPTR REFERRED TO IN 1000203.)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEYER-SCHULTE GEL OVAL BREAST IMPLANT | FTR | V. MUELLER DIV. BAXTER HEALTHCARE CORP. | STYLE 6000 | 226180 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |