D
Patient 1
THE PT UNDERWENT A VAGINAL MYOMECTOMY FOLLOWED BY A CURETTAGE AND WAS RELEASED HOME 23 DAYS LATER.
MAUDE MDR 806353
- MDR report key
- 806353
- Report number
- 9615058-2006-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2006-04-06
- Date received
- 2007-01-04
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- ORI LUBIN, MANAGER
- Address
- 5 NACHUM HETH STREET P.O. BOX 2039 TIRAT CARMEL 31290 IS
- Phone
- 972-972-9724
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EXABLATE 2000 | FOCUSED ULTRASOUND | INSIGHTEC, LTD. | MIK | EXABLATE 2000 | * | * | N | N | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2007-01-04 | 0 | 1. H; 2. R |