MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-07-02 for OPTUNE TFH-91000 N/A manufactured by Novocure, Ltd..
[112859402]
Novocure medical opinion is that a contribution of the array placement to the event cannot be ruled out. Contributing factors for wound dehiscence in this patient include prior radiation, chemotherapy, and prior surgery affecting skin integrity. Wound dehiscence 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
[112859403]
A (b)(6) female patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2017. On (b)(6) 2018, novocure was informed by the prescribing physician that the patient had been hospitalized due to a skin tear and exposed hardware. Optune therapy was discontinued. Per medical history, the patient first reported non-serious skin lesions during a clinic visit on (b)(6) 2018 and was treated with neomycin/polymyxin/bacitracin ointment. On (b)(6) 2018, the patient experienced a recurrence of the event which resulted in a 12 day treatment break from optune therapy. On (b)(6) 2018 the patient resumed optune therapy and on (b)(6) 2018, the patient's scalp was described as improved. On (b)(6) 2018, the prescriber reported that the patient's prior skin ulcer, which had been superficial and healed, had developed into a wound with exposed surgical hardware. Patient was admitted to the hospital and underwent surgical repair. Intravenous antibiotics were given and the patient remained in stable condition. The patient was not on bevacizumab or steroids at the time of the event. The prescriber stated that optune therapy did contribute to the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009453079-2018-00104 |
| MDR Report Key | 7654339 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-07-02 |
| Date of Report | 2018-07-02 |
| Date of Event | 2018-06-07 |
| Date Mfgr Received | 2018-06-07 |
| Device Manufacturer Date | 2016-06-19 |
| Date Added to Maude | 2018-07-02 |
| 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 | 2018-07-02 |
| 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. Hospitalization; 2. Required No Informationntervention | 2018-07-02 |