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	04/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure medical opinion is that the contribution of the array placement to the skin 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 73-year-old female patient with newly diagnosed glioblastoma (gbm) started optune gio therapy on (b)(6) 2023.On (b)(6) 2025, novocure was informed by the patient's neurologist that she had been experiencing persistent, intermittent pruritus and erythema of the scalp, occurring daily and attributed to optune gio therapy.The current treatment regimen included gabapentin 200 mg twice daily, diphenhydramine 12.5 mg as needed, and hydroxyzine 5-10 mg as needed if diphenhydramine was ineffective.Additionally, the patient applied clobetasol cream to affected areas when erythematous and temporarily discontinued therapy until symptoms resolved.On (b)(6) 2025, the healthcare provider (hcp) reported that the patient was advised to use witch hazel as an alternative to standard alcohol-based skin preparation.A water-based skin barrier could be applied following witch hazel use.The hcp also recommended the use of topical antihistamines and corticosteroids between array changes to prevent or manage hypersensitivity reactions and pruritus.The prescribing physician advised increasing the gabapentin dosage to 200 mg three times daily to assess improved efficacy.The hcp did not provide a causality assessment; however, it was noted that the patient believed the symptoms were related to optune gio therapy and alcohol wipes.The patient remained on 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: 22025466
• Report Number: 3010457505-2025-00506
• Device Sequence Number: 7136206
• Product Code: NZK
• UDI-Device Identifier: 07290107982207
• UDI-Public: (01)07290107982207(11)191023
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/15/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMLODIPINE; CALCIUM CITRATE; CYANOCOBALAMIN; DICYCLOMINE; ERGOCALCIFEROL; FEXOFENADINE; FLAXSEED OIL; HYDROCODONE-ACETAMINOPHEN; KRILL-OMEGA-3-DHA; LACTULOSE; LEVOTHYROXINE; LOSARTAN; MIRTAZAPINE; ONDANSETRON; OXYBUTYNIN; PANTOPRAZOLE; PROCHLORPERAZINE; TEMOZOLOMIDE; TIZANIDINE; TRAMADOL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female