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	09/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure's medical opinion is that the contribution of the array placement to the skin irritation/inflammation that required medical intervention with a wound care specialist, 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 77-year-old female patient with newly diagnosed glioblastoma (gbm) began optune gio therapy on (b)(6) 2022.On (b)(6) 2025, the patient informed novocure that the prescribing physician had referred her to a wound care specialist due to skin concerns on the scalp that occurred on (b)(6) 2025.The patient noted the skin appeared more bruised with open sores, peeling skin, and raised bumps on the right side of the head.Optune gio therapy was temporarily discontinued.The images provided showed a raised, erythematous lesion with a central pale area accompanied by a second smaller lesion.Additional findings included yellowish crusting, small erosions in the vicinity of the lesions, and mild to moderate erythema throughout the scalp.Attempts were made to contact the prescribing physician for additional information; however, no response was received.
Additional Manufacturer Narrative
Novocure received additional information on october 21, 2025, that the patient experienced significant skin irritation which resulted in extended time off optune gio therapy.On an unspecified date, the patient consulted a dermatologist, who performed a biopsy of the scalp.The biopsy results indicated squamous cell carcinoma.The patient was scheduled to meet with a surgeon to discuss mohs surgery.She anticipated being unable to continue with optune gio therapy for several months, therefore discontinued therapy.Novocure medical opinion is that the squamous cell carcinoma was not related to device use.

• 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: 23298120
• Report Number: 3010457505-2025-00598
• Device Sequence Number: 11977455
• Product Code: NZK
• UDI-Device Identifier: 07290107982207
• UDI-Public: (01)07290107982207(11)171220
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2017
• 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: ACETAMINOPHEN.; BACITRACIN ZINC TOPICAL.; DEXAMETHASONE.; FOLIC ACID.; LEVETIRACETAM.; MULTIVITAMIN WITH MINERALS.; OCULAR LUBRICANT.; OXYCODONE.; PROBIOTIC FORMULA.; SENNA.; TEMOZOLOMIDE.; VITAMIN B12.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female