FDA Adverse Event
Injury
Summary report: N
NOVASURE IMPEDANCE CONTROLLED EA SYSTEM
MDR report key: 923609
·
Received October 3, 2007
Report
- Report Number
- 1222780-2007-00027
- Event Type
- Injury
- Date Received
- October 3, 2007
- Date of Event
- August 28, 2007
- Report Date
- September 6, 2007
- Manufacturer
- CYTYC SURGICAL PRODUCTS
- Product Code
- MNB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED TO CYTYC SURGICAL PRODUCTS, THEREFORE AN INVESTIGATION WAS UNABLE TO BE PERFORMED. BECAUSE THE LOT NUMBER WAS NOT PROVIDED, AN INVESTIGATION OR REVIEW OF THE DEVICE HISTORY RECORD FOR THE DEVICE WAS NOT ABLE TO BE PERFORMED. NO FURTHER INFORMATION COULD BE OBTAINED THUS NO CONCLUSION CAN BE DRAWN FOR THIS EVENT.
Description of Event or Problem · 1
USER FACILITY REPORTED 24 HOURS POST UNEVENTFUL UTERINE ABLATION USING THE NOVASURE SYSTEM, THE PATIENT PRESENTED TO THE ER WITH PAIN AND FEVER. THE PATIENT WAS ADMITTED AND BLOOD CULTURES WERE POSITIVE FOR GROUP B STREPTOCOCCUS. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS AND RELEASED FOUR DAYS LATER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NOVASURE IMPEDANCE CONTROLLED EA SYSTEM | RADIO FREQUENCY ENDOMETRIAL ABLATION | MNB | CYTYC SURGICAL PRODUCTS | NS2000 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Hospitalization| R |