MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-07-11 for OPTUNE TFH9100 N/A manufactured by Novocure, Ltd..
[113672769]
Novocure agrees with the prescribing physician, that the event was caused by the patient tripping over the device cord. Other contributing factors include: history of frequent falls, muscular weakness, peripheral edema and left sided hemiparesis. Hip fracture 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 the tmz arm of the trial (<1%) only.
Patient Sequence No: 1, Text Type: N, H10
[113672770]
A (b)(6) male with newly diagnosed glioblastoma began optune therapy on (b)(6) 2018. On (b)(6) 2018, the patient's brother reported that the patient had fallen and broke his hip on (b)(6) 2018. The patient was hospitalized and required hip surgery. On (b)(6) 2018, the prescribing physician confirmed that the patient's hip fracture was caused by tripping over the optune device cord. At the time of the report, the patient was in rehab and was continuing optune therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009453079-2018-00103 |
| MDR Report Key | 7677960 |
| Report Source | CONSUMER |
| Date Received | 2018-07-11 |
| Date of Report | 2018-07-11 |
| Date of Event | 2018-06-13 |
| Date Mfgr Received | 2018-06-19 |
| Device Manufacturer Date | 2017-07-10 |
| Date Added to Maude | 2018-07-11 |
| 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 BUILDING, SHA'AR HACARMEL 4TH FLOOR |
| Manufacturer City | HAIFA 31905 |
| Manufacturer Country | US |
| Manufacturer Postal | 31905 |
| Manufacturer Phone | 9724850120 |
| Manufacturer G1 | NOVOCURE, LTD. |
| Manufacturer Street | TOPAZ BUILDING, SHA'AR HACARMEL 4TH FLOOR |
| Manufacturer City | HAIFA, 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 | 2018-07-11 |
| Model Number | TFH9100 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 11 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOVOCURE, LTD. |
| Manufacturer Address | TOPAZ BUILDING, SHA'AR HACARMEL 4TH FLOOR HAIFA, 31905 IS 31905 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-07-11 |