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	05/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A 76-year-old male with newly diagnosed glioblastoma (gbm) started optune gio therapy on (b)(6) 2026.On (b)(6) 2026, novocure received a report indicating that the patient experienced severe scalp pruritus.The patient contacted a physician and was prescribed an unspecified medication described as stronger than diphenhydramine.The patient reported that the medication caused significant drowsiness, prompting a switch to fexofenadine hydrochloride.It was further reported that the patient had used a triple antibiotic ointment and topical diphenhydramine on the scalp.According to the patient, the skin on the entire body was very pruritic, and the patient experienced excessive sweating, which was attributed to temozolomide therapy.The report additionally noted altered taste sensation, significant fatigue, and stomach discomfort, which the patient also attributed to temozolomide.On (b)(6) 2026, the patient reported that he was recommended by a healthcare provider to use zinc oxide cream for scalp itchiness.Multiple 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 cannot be ruled out.Drowsiness, sweating, altered taste sensation, fatigue and stomach discomfort were unrelated to device use.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 ; 2077527602
• MDR Report Key: 25442775
• Report Number: 3010457505-2026-00756
• Device Sequence Number: 5740587
• Product Code: NZK
• UDI-Device Identifier: 07290107986427
• UDI-Public: (01)07290107986427(11)TFH208005
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P100034/S033
• 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): 06/09/2026

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
• Device Lot Number: N/A
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2019
• 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: 76 YR
• Patient Sex: Male