FDA Adverse Event
Injury
Summary report: N
NOVASURE IMPENDANCE CONTROLLED EA SYSTEM
MDR report key: 923610
·
Received October 3, 2007
Report
- Report Number
- 1222780-2007-00031
- Event Type
- Injury
- Date Received
- October 3, 2007
- Date of Event
- August 31, 2007
- Report Date
- September 4, 2007
- Manufacturer
- CYTYC SURGICAL PRODUCTS
- Product Code
- MNB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- 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 WITH A FEVER. DOCUMENTATION OF GROUP B STREPTOCOCCUS WAS NOTED FROM THE BLOOD CULTURES AND THE PATIENT DEMONSTRATED EVIDENCE OF SEPSIS. IV ANTIBIOTICS AND SUPPORTIVE ICU CARE FOLLOWED. THE PATIENT RESPONDED WELL TO TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NOVASURE IMPENDANCE CONTROLLED EA SYSTEM | RADIO FREQUENCY ENDOMETRIAL ABLATION | MNB | CYTYC SURGICAL PRODUCTS | NS2000 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Hospitalization| R |