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	10/08/2025
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 requiring medical intervention 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 74-year-old female patient with newly diagnosed glioblastoma (gbm) began optune gio therapy on (b)(6) 2023.On (b)(6) 2025, the patient's spouse notified novocure that the patient had developed erythema and sores on the scalp.The patient was advised by a healthcare provider (hcp) to discontinue optune gio therapy for two weeks.On january 02, 2026, novocure received a medical record dated on (b)(6) 2025, documenting a significant worsening of the patient's scalp condition.It was recommended that the patient temporarily discontinue optune gio therapy until scalp recovery and consult a dermatologist.The patient was prescribed clobetasol 0.05% solution, mupirocin 2% ointment, and gabapentin 100 mg for neuropathic pain and pruritus.On (b)(6) 2025, novocure was informed that the patient's scalp condition had improved, and the patient was advised by the hcp to resume optune gio therapy.Multiple attempts were made to contact the prescribing physician; however, no response was received.
Additional Manufacturer Narrative
On february 03, 2026, novocure received additional information from the prescribing physician indicating that the skin reaction was related to optune gio therapy and that the patient had discontinued device use in (b)(6) 2026.On the same day novocure also received a medical record dated on october 14, 2025, documenting that the patient had applied moisturizing cream, which resulted in improvement of symptoms and reduction of pruritus.During physical examination, scalp irritation with open areas, erythema, scabbing, and scaling were observed.Purulent crusting was noted on the posterior scalp, raising concern for a skin infection.Overall skin condition was reported to have improved compared with previous evaluations.Two photographs were included in the record showing the top and left side of the scalp.On the left side above the ear, multiple lesions with moderate erythema and mild eschar were present.The top of the scalp demonstrated diffuse mild to moderate erythema with small areas of scaling.The patient was assessed as having contact dermatitis of the scalp and was prescribed fluocinolone acetonide oil to alleviate stinging sensations attributed to clobetasol use.In addition, the patient was advised to take an unspecified oral antibiotic twice daily to address a possible superficial skin infection.

• 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: 24177978
• Report Number: 3010457505-2026-00679
• Device Sequence Number: 9569836
• Product Code: NZK
• UDI-Device Identifier: 07290107982207
• UDI-Public: (01)07290107982207(11)160412
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2026

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: 01/02/2026
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2016
• 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: ACETAMINOPHEN; ATORVASTATIN; CARBOXYMETHYLCELLULOSE SODIUM; LEVETIRACETAM; ONDANSETRON; PANTOPRAZOLE; SERTRALINE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female