FDA Adverse Event
Injury
Summary report: N
ESSURE
MDR report key: 1525401
·
Received November 6, 2009
Report
- Report Number
- 2951250-2009-00065
- Event Type
- Injury
- Date Received
- November 6, 2009
- Date of Event
- January 1, 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
- MA, 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 REMOVAL OF TWO ESSURE MICRO-INSERTS WAS NECESSARY, DUE TO SEVERE PELVIC PAIN HIS PT WAS EXPERIENCING. THE PAIN RESOLVED FOLLOWING REMOVAL. THE PHYSICIAN DID NOT HAVE FURTHER DETAILS AT THE TIME THIS EVENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ESSURE | INSERT, TUBAL OCCLUSION | HHS | BAYER PHARMA AG | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |