FDA Adverse Event
Other
Summary report: N
ESSURE
MDR report key: 1200379
·
Received October 10, 2008
Report
- Report Number
- 2951250-2008-00027
- Event Type
- Other
- Date Received
- October 10, 2008
- Date of Event
- September 29, 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
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PHYSICIAN REPORTED A PATIENT WHO EXPERIENCED SEVERE EPIGASTRIC PAIN 10 DAYS FOLLOWING ESSURE MICRO-INSERT PLACEMENT IN WHICH MULTIPLE MICRO-INSERTS WERE PLACED IN EACH FALLOPIAN TUBE. PATIENT PRESENTED TO THE ER FOR PAIN AND WAS HOSPITALIZED. FLAT PLATE X-RAY SHOWED PERFORATION: ONE MICRO-INSERT IN THE EPIGASTRIC AREA AND ANOTHER IN THE CUL-DE-SAC. PATIENT UNDERWENT SURGERY; ONE MICRO-INSERT WAS REMOVED FROM THE BOWEL AND ONE WAS REMOVED FROM THE POSTERIOR CUL-DE-SAC. THE OTHER MICRO-INSERT APPEARED PROPERLY POSITIONED IN THE CONTRALATERAL TUBE AND WAS LEFT IN PLACE. BOTH TUBES WERE LIGATED. PATIENT WAS LATER DISCHARGED ON PAIN MEDICATIONS AND STATED HER PAIN HAD SUBSTANTIALLY DECREASED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ESSURE | INSERT, TUBAL OCCLUSION | HHS | CONCEPTUS, INC. | ESS305 | 627301 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |