FDA Adverse Event
Other
Summary report: N
ESSURE
MDR report key: 1353988
·
Received March 31, 2009
Report
- Report Number
- 2951250-2009-00013
- Event Type
- Other
- Date Received
- March 31, 2009
- Date of Event
- February 20, 2009
- Report Date
- January 19, 2017
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ECTOPIC PREGNANCY. PHYSICIAN REPORTED PT WITH ECTOPIC PREGNANCY (DATE OF REPORTED PREGNANCY (B) (6) 2008) 14 MONTHS FOLLOWING THE ESSURE PROCEDURE (DATE OF PROCEDURE (B) (6) 2007). HSG ((B) (6) 2008) REPORTED THAT MICRO-INSERTS APPEARED PROPERLY PLACED AND THAT OCCLUSION WAS DEMONSTRATED. CONCEPTUS HAS NOT REVIEWED HSG FILMS. THE PREGNANCY WAS DISCONTINUED IN (B) (6) 2008 AND A HYSTERECTOMY WAS PERFORMED ON (B) (6) 2009. DURING THE HYSTERECTOMY, IT WAS NOTED THAT THE MICRO-INSERT WAS NO LONGER IN THE PROPER LOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ESSURE | INSERT, TUBAL OCCLUSION | HHS | BAYER PHARMA AG | ESS305 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |