FDA Adverse Event
Summary report: N
SURGITEK TEARDROP Q-S ADJUSTABLE BILUMEN IMPLANT
MDR report key: 13923
·
Received June 10, 1994
Report
- Report Number
- MW1002435
- Date Received
- June 10, 1994
- Manufacturer
- MEDICAL ENGINEERING CORP.
- Product Code
- FTR
- Report Source
- Voluntary report
- Reporter Occupation
- NO INFORMATION
Narratives
Description of Event or Problem · 1
RPTR COMPLAINS OF LEAKING AND CAPSULAR CONTRACTURE OF ONE IMPLANT AND FULL-BLOWN RUPTURE OF THE OTHER IMPLANT. (SAME RPTR REFERRED TO IN 1002432, 1002433, AND 1002434.)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURGITEK TEARDROP Q-S ADJUSTABLE BILUMEN IMPLANT Implant | SILICONE BILUMEN IMPLANT | FTR | MEDICAL ENGINEERING CORP. | 32167-88H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR |