MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-07-20 for OPTUNE TFH-9100 N/A manufactured by Novocure Ltd.
[80544534]
Novocure medical opinion is that the fall and subsequent fractures and contusions were related to optune due to the involvement of the device cord in the mechanical fall. Fall is a known event with device use and was reported as an adverse event in the ef-14 trial of optune together with temozolomide (tmz) compared to tmz alone in patients with newly diagnosed gbm in both arms of the trial (8% and 3% in optune/tmz and tmz arms respectively).
Patient Sequence No: 1, Text Type: N, H10
[80544535]
A (b)(6) patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2017. On (b)(6) 2017, it was reported that the patient had been admitted to the hospital the previous day following a fall that morning. The patient reported that they were walking to the bathroom, tripped on the device cad (i. E. , the connection cable and box, specifically the cable which runs between the electric field generator/"the device" and the array wires), and fell backwards. The patient suffered a compression fracture, several broken ribs, and bruises on her legs and back. The patient was treated with po pain medication (morphine). The patient temporarily discontinued optune therapy use upon admission, but planned to restart therapy during the hospitalization. Prescribing physician was contacted for additional information with no response.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009453079-2017-00088 |
| MDR Report Key | 6727985 |
| Report Source | CONSUMER |
| Date Received | 2017-07-20 |
| Date of Report | 2017-08-10 |
| Date of Event | 2017-06-25 |
| Date Mfgr Received | 2017-08-01 |
| Device Manufacturer Date | 2016-10-10 |
| Date Added to Maude | 2017-07-20 |
| 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 | 3 |
| Manufacturer Contact | DR. EILON KIRSON |
| Manufacturer Street | TOPAZ BIULDING, SHA'AR HACARMEL 4TH FLOOR |
| Manufacturer City | HAIFA 31905 |
| Manufacturer Country | US |
| Manufacturer Postal | 31905 |
| Manufacturer G1 | NOVOCURE LTD |
| Manufacturer Street | TOPAZ BUILDING, SHA'AR HACARMEL 4TH FLOOR |
| Manufacturer City | HAFIA, 31905 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 31905 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTUNE |
| Generic Name | OPTUNE |
| Product Code | NZK |
| Date Received | 2017-07-20 |
| Model Number | TFH-9100 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 8 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOVOCURE LTD |
| Manufacturer Address | TOPAZ BUILDING, SHA'AR HACARMEL 4TH FLOOR HAIFA 31905 US 31905 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-07-20 |