FDA Adverse Event
Other
Summary report: N
ESSURE
MDR report key: 1122359
·
Received August 15, 2008
Report
- Report Number
- 2951250-2008-00019
- Event Type
- Other
- Date Received
- August 15, 2008
- Date of Event
- July 31, 2008
- Report Date
- February 14, 2017
- Manufacturer
- CONCEPTUS, INC.
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS.
Description of Event or Problem · 1
PHYSICIAN REPORTED THAT A PATIENT WHO HAD ESSURE PLACED PRESENTED WITH A COMPLAINT OF PAIN IN THE LOWER QUADRANT SINCE PLACEMENT. PATIENT WAS HOSPITALIZED FOR PAIN MANAGEMENT. MICRO-INSERTS REMOVED VIA LAPAROSCOPY, BILATERAL SALPINGECTOMY. PATIENT WAS DOING BETTER POSTOPERATIVELY AND SENT HOME ON ORAL NARCOTICS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ESSURE | INSERT, TUBAL OCCLUSION | HHS | CONCEPTUS, INC. | ESS305 | 626812 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |