FDA Adverse Event
Malfunction
Summary report: N
ESSURE
MDR report key: 2093199
·
Received April 13, 2011
Report
- Report Number
- 2951250-2011-00021
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Date of Event
- August 17, 2010
- Report Date
- January 19, 2017
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, 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
A PHYSICIAN REPORTED A PATIENT WHO REQUIRED SURGERY POST ESSURE PLACEMENT. ON (B)(6) 2010 FOLLOW UP WITH PHYSICIAN: DR. REPORTED IT WAS MEDICALLY NECESSARY TO REMOVE THE DEVICE AS IT WAS FOUND OVERLYING THE LOWER ANTERIOR BODY. IT WAS SURGICALLY REMOVED AND A RIGHT TUBAL LIGATION WAS PERFORMED. THE PATIENT WHO WAS EXPERIENCING SEVERE LOWER QUADRANT PAIN, WAS GIVEN MEDICATION AND IS NOW MUCH IMPROVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ESSURE | INSERT, TUBAL OCCLUSION | HHS | BAYER PHARMA AG | ESS305 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Required Intervention |