MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE GIO

Model Number	TFH9100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	09/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure's medical opinion is that the contribution of the transducer arrays to the skin inflammation/irritation cannot be ruled out.Medical device site reaction is an expected event with optune gio device use (ef-11 16% and 53% ef-14 optune arm).
Event or Problem Description
A 61-year-old female patient with newly diagnosed glioblastoma (gbm) initiated optune gio therapy on (b)(6) 2024.On (b)(6) 2025, novocure received a medical record dated (b)(6) 2025, indicating that the patient developed a rash associated with optune gio therapy.The rash was unresponsive to topical clobetasol and diphenhydramine cream.It resolved following the administration of dexamethasone, which had originally been prescribed on (b)(6) 2024, for gait disturbance and nausea unrelated to optune gio therapy.Due to the persistence of the rash, the patient was advised to initiate low-dose prednisone therapy.Prednisone 10 mg was subsequently prescribed.On (b)(6) 2025, the healthcare provider confirmed that the patient had been prescribed 5 mg of prednisone daily for the management of skin irritation associated with optune gio therapy.The patient was also receiving bevacizumab at that time and continued optune gio therapy.

• Brand Name: OPTUNE GIO
• Common Device Name: OPTUNE GIO
• Manufacturer (Section D): NOVOCURE GMBH; neuhofstrasse 21; baar, 6340 ; SZ 6340
• Manufacturer (Section G): NOVOCURE GMBH; neuhofstrasse 21; baar, 6340 ; SZ 6340
• Manufacturer Contact: sharon perez ; 180 hanover st.; portsmouth, NH 03801 ; 2077527602
• MDR Report Key: 23485326
• Report Number: 3010457505-2025-00606
• Device Sequence Number: 10559111
• Product Code: NZK
• UDI-Device Identifier: 07290107982207
• UDI-Public: (01)07290107982207(11)160426
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P100034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: TFH9100
• Device Catalogue Number: TFH9100US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMITRIPTYLINE; AMLODIPINE; ATORVASTATIN; CLOBETASOL; DEXAMETHASONE; EPINEPHRINE; HYDROXYZINE; LORAZEPAM; LOSARTAN; ONDANSETRON
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 98 KG