FDA Adverse Event
Injury
Summary report: N
MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM
MDR report key: 830594
·
Received March 22, 2007
Report
- Report Number
- 9710493-2007-00004
- Event Type
- Injury
- Date Received
- March 22, 2007
- Date of Event
- February 28, 2007
- Report Date
- March 22, 2007
- Manufacturer
- MICROSULIS MEDICAL LTD.
- Product Code
- MNB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE COMPANY ANALYZED THE MEA SYSTEM'S TREATMENT DATA FILE ASSOCIATED WITH THIS EVENT. THE CONCLUSIONS OF THE ANALYSIS WERE THAT BOTH THE APPLICATOR AND THE MEA SYSTEM WERE FUNCTIONING WITHIN OPERATING SPECIFICATIONS AT THE TIME OF THE TREATMENT, AND NO MALFUNCTIONS OR PERFORMANCE DEVIATIONS WERE PRESENT.
Description of Event or Problem · 1
PATIENT WAS TREATED WITH A REUSABLE APPLICATOR WITHOUT INCIDENT. USER FACILITY REPORTED THERMAL INJURY TO ADJACENT TISSUE REQUIRING SURGICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM | MICROWAVE ENDOMETRIAL ABLATION DEVICE | MNB | MICROSULIS MEDICAL LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention |