FDA Adverse Event
Injury
Summary report: N
ESSURE
MDR report key: 3525208
·
Received December 13, 2013
Report
- Report Number
- MW5033482
- Event Type
- Injury
- Date Received
- December 13, 2013
- Date of Event
- December 12, 2013
- Report Date
- December 12, 2013
- Manufacturer
- BAYER
- Product Code
- HHS
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
I HAD THE ESSURE PROCEDURE ON (B)(6) 2013. ON (B)(6) 2013, I HAD MY F/U HSG TO SEE IF THE TUBES WERE BLOCKED. THIS REVEALED THAT ONE COIL HAS NOT FOLLOWED THE PATH OF A SEEMINGLY NORMAL FALLOPIAN TUBE; THE COIL APPEARS TO HAVE PERFORATED THE FALLOPIAN TUBE. MORE CONSULTATION/TESTING IS TO COME.
Description of Event or Problem · 1
ADD'L INFO RECEIVED FROM REPORTER ON (B)(6) 2013 FOR REPORT NUMBER MW5033482. PT CALLED TO PROVIDE UPDATED INFO THAT SHE HAD AN MRI ON (B)(6) 2013, WHICH INDICATED THE LEFT COIL WAS IN THE UTERINE MUSCLE. SHE SAID SHE IS STILL WAITING TO FIND OUT WHAT THE NEXT STEP WILL BE. SHE MENTIONED SHE IS CONCERNED WHAT WILL HAPPEN DURING HER NEXT MENSTRUAL CYCLE. PT SAID SHE WILL CALL OR FAX IN ANY OTHER UPDATES OR ADD'L INFO AS NEEDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 652990 | ESSURE | ESSURE | HHS | BAYER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Other |