MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-01-28 for INSIGHTEC EXABLATE 2000 manufactured by Insightec.
[1415781]
I am not sure that the device -insightec exablate 2000- had anything to do with my diagnosis of uterine cancer, but i wanted to report it, just in case other women who were treated with hifu for uterine fibroids later developed uterine cancer. I was treated at (b) (6) with hifu, using the insightec exablate 2000, in 2007. I developed uterine cancer approximately a half after having the treatment -diagnosed in 2009-. Fortunately, it was caught at stage 1 and i had a hysterectomy -in (b) (6) 2009- and have not had to have any further treatment. I did report this to dr (b) (6), who administered the treatment to me, at (b) (6), and to insightec. Diagnosis or reason for use: large uterine fibroid - in 2007 at (b) (6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5014591 |
| MDR Report Key | 1593109 |
| Date Received | 2010-01-28 |
| Date of Report | 2010-01-28 |
| Date of Event | 2009-01-01 |
| Date Added to Maude | 2010-02-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INSIGHTEC EXABLATE 2000 |
| Generic Name | NONE |
| Product Code | MIK |
| Date Received | 2010-01-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INSIGHTEC |
| Manufacturer Address | 4851 LBJ FREEWAY STE. 400 DALLAS TX 75244 US 75244 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other | 2010-01-28 |