MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2006-11-01 for EXABLATE 2000 * manufactured by Insightec, Ltd..
[534270]
The patient had a significant skin burn that was noted on the phase contrast images and the treatment was prematurely terminated after over 55 sonications. The sc fat was obviously abnormal on the temperature maps on the sagital images. She was asked repeatedly if she was having any skin burning sensation, but repeatedly said it was deep heat and was sleeping during much of the procedure. The patient complained of deep heat and had stopped the rx only twice due to heat at the skin surface. Today, the patient has a quite large 8x5cm burnt skin area that will most likely slough. Patient has been recommended for a skin graft. There are additional blisters outside the burnt area.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615058-2006-00002 |
| MDR Report Key | 780599 |
| Report Source | 05,07 |
| Date Received | 2006-11-01 |
| Date of Report | 2006-10-04 |
| Date of Event | 2006-09-27 |
| Date Mfgr Received | 2006-09-29 |
| Date Added to Maude | 2006-11-15 |
| 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 | MRGFUS |
| Product Code | MIK |
| Date Received | 2006-11-01 |
| Model Number | EXABLATE 2000 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 768377 |
| Manufacturer | INSIGHTEC, LTD. |
| Manufacturer Address | 5 NACHUM HETH STREET P. O. 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 | 2006-11-01 |