FDA Adverse Event
Injury
Summary report: N
BREAST IMPLANT, 370 CC
MDR report key: 10996
·
Received January 21, 1994
Report
- Report Number
- MW1000433
- Event Type
- Injury
- Date Received
- January 21, 1994
- Report Date
- January 10, 1994
- Manufacturer
- MCGHAN MEDICAL CORP.
- Product Code
- FTR
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IL, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
RPTR HAD BREAST IMPLANT SURGERY IN 1982 TO CORRECT A BIRTH DEFECT. WITHIN SEVERAL YRS SHE DEVELOPED CAPSULAR CONTRACTION IN LEFT BREAST TO THE POINT WHERE IT WAS PAINFUL TO SLEEP ON HER STOMACH. IN 1989, RPTR HAD THE LEFT BREAST IMPLANT REMOVED AND REPLACED WITH THIS CO'S IMPLANT WITH THE HOPE OF PREVENTING THE CAPSULAR CONTRACTION. WITHIN A COUPLE OF YRS, THE SAME PROBLEM DEVELOPED IN HER LEFT BREAST. DATE EVENT OCCURRED: 1984 AND 1990. (ALSO SEE MEDWATCH 1000432.)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BREAST IMPLANT, 370 CC Implant | FTR | MCGHAN MEDICAL CORP. | STYLE 40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Required Intervention |