FDA Adverse Event
Injury
Summary report: N
MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM
MDR report key: 1613308
·
Received February 19, 2010
Report
- Report Number
- 9710493-2010-00001
- Event Type
- Injury
- Date Received
- February 19, 2010
- Report Date
- February 18, 2010
- Manufacturer
- MICROSULIS MEDICAL LTD.
- Product Code
- MNB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFO REGARDING SPECIFIC PT DETAILS REQUESTED FROM FACILITY BY (B) (4). INFO HAS NOT YET BEEN PROVIDED FROM FACILITY. EVAL OF THE MEA SYSTEM DOWNLOAD WILL BE EVALUATED WHEN ADD'L INFO IS AVAILABLE.
Description of Event or Problem · 1
PT WAS TREATED WITH A DISPOSABLE MEA APPLICATOR. THE PT RETURNED ONE DAY POST MEA WITH COMPLAINT OF ABDOMINAL PAIN. THERMAL INJURY NOTED TO BOWEL. NO ADD'L INFO IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM | MICROWAVE ENDOMETRIAL ABLATION | MNB | MICROSULIS MEDICAL LTD. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization |