FDA Adverse Event
Injury
Summary report: N
SURGITEK - MEDICAL ENGINEERING CORP
MDR report key: 269606
·
Received March 15, 2000
Report
- Report Number
- MW1018405
- Event Type
- Injury
- Date Received
- March 15, 2000
- Report Date
- March 7, 2000
- Manufacturer
- MEDICAL ENGINEERING CORP.
- Product Code
- FTR
- Report Source
- Voluntary report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
HISTORY OF FIBERCYSTIC DISEASE. BILATERAL SUBCUTANEOUS MASTECTOMY AND IMMEDIATE RECONSTRUCTION OF BREAST CONTOUR. MONTHS LATER UNDERWENT BILATERAL REMOVAL OF BECKER TISSUE EXPANDERS - REPLACED WITH SURGITEK IMPLANTS 450CC BILATERALLY. 13 YRS LATER IMPLANT PROBLEMS. CAPSULAR CONTRACTURES, ASYMMETRY ON LEFT. CHANGES IN BREASTS. POSSIBLE LEAKING LT IMPLANT. CAPSULATED (RUPTURED). 3/7/00 BILATERAL CAPSULECTOMY AND RECONSTRUCTION WITH SILICONE GEL IMPLANTS. RT IMPLANT REMOVED INTACT. LT IMPLANT WAS INDEED RUPTURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURGITEK - MEDICAL ENGINEERING CORP | MAMMARY IMPLANTS | FTR | MEDICAL ENGINEERING CORP. | 11490S | 22702-86-A,24015-86-A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |