FDA Adverse Event
Injury
Summary report: N
MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM
MDR report key: 868725
·
Received May 12, 2007
Report
- Report Number
- 9710493-2007-00008
- Event Type
- Injury
- Date Received
- May 12, 2007
- Date of Event
- April 26, 2007
- Report Date
- June 21, 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
ADD'L CAT #: APPL. 900-002. ADD'L DEVICE MFR DATE: APPL. 10/2004. THE COMPANY ANALYZED THE MEA SYSTEM'S TREATMENT DATA FILE AND APPLICATOR ASSOCIATED WITH THIS EVENT. THE CONCLUSIONS OF THE ANALYSIS SHOWS THAT THE MEA SYSTEM WAS 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 MEA 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 |