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	08/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A 37-year-old male patient with newly diagnosed glioblastoma (gbm) started optune gio therapy on (b)(6), 2026.On (b)(6) 2026, the patient informed novocure that he had experienced a burning sensation on his scalp while lying down.Later that night, the patient experienced the same sensation again beneath the right array.On (b)(6), 2026, the patient noticed a small, round burn-like lesion on the right occipital area of the scalp.A provided photograph depicted the back of the patient's scalp with a small, circular, moderately erythematous lesion accompanied by scaling of the surrounding skin.The patient temporarily discontinued optune gio therapy.On august 17, 2026, additional information was received indicating that the patient had been prescribed topical mupirocin and oral amoxicillin, which were initiated on (b)(6), 2026.The treating physician advised the patient to continue the treatment interruption until the skin lesion had completely healed.Attempts were made to contact the prescribing physician; however, no reply was received.
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).

• Brand Name: Optune Gio
• Common Device Name: Optune Gio
• Manufacturer (Section D): NOVOCURE GmbH
• Manufacturer Contact: sharon perez ; 180 hanover street; portsmouth, NH ; +1(207)752-7602
• MDR Report Key: 50749770
• Report Number: 3010457505-2026-00855
• Device Sequence Number: 10309246
• Product Code: NZK
• UDI-Device Identifier: 07290107986427
• UDI-Public: (01)07290107986427(11)161031
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Male