MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-10-15 for OPTUNE TFH-91000 N/A manufactured by Novocure, Ltd..
[123797530]
Novocure medical opinion is that a contribution of device to the event cannot be ruled out. Laceration 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 optune/tmz arm of the trial (<1%) only.
Patient Sequence No: 1, Text Type: N, H10
[123797531]
A (b)(6) male patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2018. On september 24, 2018, the patient's spouse reported that the patient had fallen on (b)(6) 2018 and hit his head, causing two of the ceramic discs on the transducer arrays to break, which resulted in a 5 cm laceration on the patient's head. The laceration required 14 stitches to close. Patient was not hospitalized for the event. The prescribing physician was contacted for additional information with no response.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009453079-2018-00109 |
| MDR Report Key | 7966862 |
| Report Source | CONSUMER |
| Date Received | 2018-10-15 |
| Date of Report | 2018-10-15 |
| Date of Event | 2018-09-20 |
| Date Mfgr Received | 2018-09-24 |
| Device Manufacturer Date | 2016-08-30 |
| Date Added to Maude | 2018-10-15 |
| 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 | 3 |
| Manufacturer Contact | DR. EILON KIRSON |
| Manufacturer Street | TOPAZ BUILDING, SHA'AR HACARMEL 4TH FLOOR |
| Manufacturer City | HAIFA, 31905 |
| Manufacturer Country | IS |
| Manufacturer Postal | 31905 |
| 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 | 2018-10-15 |
| Model Number | TFH-91000 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 2 YR |
| 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. Required No Informationntervention | 2018-10-15 |