MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2007-01-04 for EXABLATE 2000 * manufactured by Insightec, Ltd..
[571198]
The pt underwent a vaginal myomectomy followed by a curettage and was released home 23 days later.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615058-2006-00001 |
| MDR Report Key | 806353 |
| Report Source | 01,07 |
| Date Received | 2007-01-04 |
| Date of Report | 2006-08-15 |
| Date of Event | 2006-04-06 |
| Date Mfgr Received | 2006-04-30 |
| Date Added to Maude | 2007-01-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ORI LUBIN, MANAGER |
| Manufacturer Street | 5 NACHUM HETH STREET P.O. BOX 2039 |
| Manufacturer City | TIRAT CARMEL 31290 |
| Manufacturer Country | IS |
| Manufacturer Postal | 31290 |
| Manufacturer Phone | 9724813131 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXABLATE 2000 |
| Generic Name | FOCUSED ULTRASOUND |
| Product Code | MIK |
| Date Received | 2007-01-04 |
| Model Number | EXABLATE 2000 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 793866 |
| Manufacturer | INSIGHTEC, LTD. |
| Manufacturer Address | 5 NACHUM HETH ST. PO BOX 2059 TIRAT CARMEL IS 39120 |
| Baseline Brand Name | MK2 - EXABLATE |
| Baseline Generic Name | NA |
| Baseline Model No | EXABLATE 2000 |
| Baseline Catalog No | NA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2007-01-04 |