FDA Adverse Event
Summary report: N
ESSURE
MDR report key: 3003707
·
Received March 12, 2013
Report
- Report Number
- 3003707
- Date Received
- March 12, 2013
- Date of Event
- March 6, 2013
- Report Date
- March 7, 2013
- Manufacturer
- CONCEPTUS INC.
- Product Code
- HHS
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
THE ESSURE DEVICE WAS BENT AND UNABLE TO BE INSERTED INTO PATIENT'S FALLOPIAN TUBE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?HYSTEROSCOPY WITH TUBAL OCCLUSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 103320 | ESSURE | DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE | HHS | CONCEPTUS INC. | ESS305 | A66680 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR |