FDA Adverse Event
Other
Summary report: N
ESSURE
MDR report key: 822708
·
Received February 26, 2007
Report
- Report Number
- MW1042059
- Event Type
- Other
- Date Received
- February 26, 2007
- Date of Event
- February 16, 2007
- Report Date
- February 16, 2007
- Product Code
- HHS
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
DR ATTEMPTED TO PLACE ESSURE DEVICE INTO RIGHT TUBE. DEVICE DID NOT TRIGGER - LOT# 621809. SHE THEN ATTEMPTED TO PLACE ITEM #622306 (#1). NOTED LIP OF DEVICE #622306 (#2) WAS SUCCESSFULLY PLACED INTO LEFT FALLOPIAN TUBE. DR THEN ATTEMPTED TO PLACE #621800 (#1) INTO RIGHT FALLOPIAN TUBE. THE ITEM AGAIN DID NOT TRIGGER CORRECTLY AND REMOVED FROM PT. ITEM #621800 (#2) RETURNED UNOPENED. DR AT THAT TIME MADE DECISION TO PERFORM CAP TUBAL TO RIGHT TUBE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 0 | ESSURE | * | HHS | * | 621800 | ||
| 1 | ESSURE | * | HHS | * | * | 621809 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Other |