FDA Adverse Event
Injury
Summary report: N
MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM
MDR report key: 856323
·
Received May 29, 2007
Report
- Report Number
- 9710493-2007-00007
- Event Type
- Injury
- Date Received
- May 29, 2007
- Date of Event
- April 25, 2007
- Report Date
- May 29, 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 MEA SYSTEM RECORDS DATA FOR EACH PATIENT TREATMENT PROCEDURE, INCLUDING SYSTEM PARAMETERS AND PATIENT DATA ENTERED BY THE PHYSICIAN. THE COMPANY ANALYZED THE MEA SYSTEM'S TREATMENT DATA FILE ASSOCIATED WITH THIS EVENT. THE CONCLUSION OF THE ANALYSIS WAS THAT THE MEA SYSTEM WAS FUNCTIONING WITHIN OPERATING SPECIFICATIONS AT THE TIME OF THE TREATMENT, AND NO MALFUNCTIONS OR PERFORMANCE DEVIATIONS WERE PRESENT. THE APPLICATOR WAS DISPOSED OF BY THE USER AND THUS COULD NOT BE ANALYZED.
Description of Event or Problem · 1
PATIENT WAS TREATED WITH A SINGLE USE FEMWAVE 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 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention |