NOVASURE
Report
- Report Number
- 1222780-2025-00001
- Event Type
- Injury
- Date Received
- January 8, 2025
- Date of Event
- December 10, 2024
- Report Date
- February 7, 2025
- Manufacturer
- HOLOGIC, INC.
- Product Code
- MNB
- PMA / PMN Number
- P010013
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- 003
Narratives
LOT AND SERIAL NUMBER OF THE DEVICE NOT PROVIDED BY THE COMPLAINANT; THEREFORE, THE UDI, EXPIRATION AND MANUFACTURING DATES ARE NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE AS THE IDENTIFICATION NUMBERS WERE NOT PROVIDED BY THE COMPLAINANT. THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED FOR EVALUATION PURPOSES THEREFORE VISUAL AND FUNCTIONAL ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED. WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE DEVICE AND THE ISSUE REPORTED. THE INFORMATION OBTAINED DURING COMPLAINT INVESTIGATION WILL BE INCLUDED IN OUR GLOBAL COMPLAINT TRENDING AND PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS TYPE FOR ADVERSE TRENDS. IF THE PRODUCT IS RECEIVED OR ADDITIONAL INFORMATION IS OBTAINED, THE INVESTIGATION WILL BE REOPENED ACCORDINGLY PER STANDARD OPERATING PROCEDURE.
THE CORRECT 510 NUMBER IS P010013
IT WAS REPORTED THAT ON DECEMBER 10TH DURING A NOVASURE PROCEDURE, THE PHYSICIAN REPORTED THAT THE CIA PASSED AND AN ABLATION WAS COMPLETED SUCCESSFULLY. PATIENT LATER FOUND A UTERINE PERFORATION VIA SOUND WHEN PERFORMING A LAPAROSCOPY. NO OTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 869723 | NOVASURE | DEVICE, THERMAL ABLATION, ENDOMETRIAL | MNB | HOLOGIC, INC. | V5 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |