MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-08-29 for EXABLATE MRGFUS 2100 ExAblate 2100 manufactured by Insightec, Ltd..
[83936938]
Device has been evaluated and determined it works per its specifications and labeled indications. Treatment resulting in alleged injury was off-label use not in accordance with approved indications. (b)(4). Note: initial report submitted to fda in 9615058-2016-00002 on 03-02-2016 but not visible in maude. Follow-up report being submitted for traceability/ documentation purposes only. There is no change from the initial report.
Patient Sequence No: 1, Text Type: N, H10
[83936939]
Treating physician reported to insightec an event related to off-label use of exablate 2100 (p040003/s016 uterine fibroids indication) on (b)(6) year old male. Per their report, the post-treatment examination of the skin showed a 5cm third degree skin burn with blistering. The center of this burn was white surrounded with a hyperemic area. The patient was prescribed for antibiotics to minimize the risk of infection and is now under the care of plastic surgery and dermatology for wound care.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615058-2016-00002 |
| MDR Report Key | 6829296 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-08-29 |
| Date of Report | 2017-08-29 |
| Date of Event | 2016-02-05 |
| Report Date | 2016-02-05 |
| Date Reported to Mfgr | 2016-02-05 |
| Date Mfgr Received | 2016-02-05 |
| Date Added to Maude | 2017-08-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. IDAN COHEN |
| Manufacturer Street | 5 NACHUM HETH STREET P.O. BOX 2039 |
| Manufacturer City | TIRAT CARMEL, ISRAEL 39120 |
| Manufacturer Country | IS |
| Manufacturer Postal | 39120 |
| Manufacturer G1 | INSIGHTEC, LTD |
| Manufacturer Street | 5 NACHUM HETH STREET P.O. BOX 2039 |
| Manufacturer City | TIRAT CARMEL, ISRAEL 39120 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 39120 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXABLATE MRGFUS |
| Generic Name | MR GUIDED FOCUSED ULTRASOUND |
| Product Code | NRZ |
| Date Received | 2017-08-29 |
| Model Number | 2100 |
| Catalog Number | ExAblate 2100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INSIGHTEC, LTD. |
| Manufacturer Address | 5 NACHUM HETH STREET P.O. BOX 2039 TIRAT CARMEL, ISRAEL 31290 IS 31290 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-08-29 |