MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-11-05 for OPTUNE TFH-91000 N/A manufactured by Novocure, Ltd..
[126069187]
Novocure medical opinion is that a contribution of the array placement to the event cannot be ruled out. Contributing factors for wound infection in this patient include underlying cancer disease and prior surgery affecting skin integrity. Wound infection is an expected 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 (<1% and <1% in optune/tmz and tmz arms respectively).
Patient Sequence No: 1, Text Type: N, H10
[126069188]
A (b)(6) female patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2018. On (b)(6) 2018, the patient's spouse informed novocure he had observed a pus-like discharge from the patient's previous resection site in the right parietal region on (b)(6) 2018. The patient was brought to the hospital and underwent a surgical repair on (b)(6) 2018, with a bone flap removal. The origin of the wound infection was noted to be from the skin surface. No additional information was provided. Optune therapy was discontinued. The prescribing physician did not provide an assessment of the relationship of the event to optune therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009453079-2018-00110 |
| MDR Report Key | 8037034 |
| Report Source | FOREIGN |
| Date Received | 2018-11-05 |
| Date of Report | 2018-11-05 |
| Date of Event | 2018-10-18 |
| Date Mfgr Received | 2018-10-20 |
| Device Manufacturer Date | 2017-11-08 |
| Date Added to Maude | 2018-11-05 |
| 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 | 2018-11-05 |
| Model Number | TFH-91000 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 1 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. Hospitalization; 2. Required No Informationntervention | 2018-11-05 |