MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE LUA

Model Number	TFT9200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	03/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A 76-year-old female patient with non-small cell lung cancer (nsclc) began optune lua therapy on (b)(6) 2025.On (b)(6) 2026, the patient reported to novocure that she had temporarily discontinued optune lua therapy due to severe itching, which was described as intense enough to disrupt her sleep.The patient reported using a skin preparation product and taking up to 2000 mg per day of unspecified anti-itching medication.On (b)(6) 2026, the patient clarified that she had been prescribed oral hydroxyzine.The patient's prescribing physician was contacted for additional information and responded on (b)(6) 2026, stating that this event had not been treated in their office and that the patient continued optune lua therapy.The physician further indicated that the prescription for hydroxyzine was likely issued by another healthcare provider.
Additional Manufacturer Narrative
Novocure's medical opinion is that the contribution of the transducer arrays placement to the skin inflammation/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).

• Brand Name: OPTUNE LUA
• Common Device Name: OPTUNE LUA
• 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: 24911724
• Report Number: 3010457505-2026-00717
• Device Sequence Number: 18413464
• Product Code: SDA
• UDI-Device Identifier: 07290107983129
• UDI-Public: (01)07290107983129(11)211210
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P230042
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/17/2026

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: TFT9200
• Device Catalogue Number: TFT9200US
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2021
• 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: APIXABAN.; BUDESONIDE.; CARVEDILOL.; FORMOTEROL.; FUROSEMIDE.; IPRATROPIUM.; LIDOCAINE.; LOSARTAN.; METHOCARBAMOL.; ONDANSETRON.; POTASSIUM CHLORIDE.; PRILOCAINE.; SALBUTAMOL.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female