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	04/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A 76-year-old male patient with non-small cell lung cancer (nsclc) began optune lua therapy on (b)(6), 2025.On (b)(6), 2026, novocure was informed that the patient had experienced a recurrence of skin irritation and was treated with prednisone.It was also reported that the patient was experiencing excessive sweating, which led to the arrays peeling off the torso.According to the available medical record dated february 06, 2026, the patient had previously discontinued prednisone 5mg in (b)(6) 2026.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 placement to the skin inflammation/irritation, cannot be ruled out.Hyperhidrosis is related to device use, although assessed as non-serious.Skin reaction has been reported in the pivotal ef- 24 clinical trial for optune lua treatment for nsclc (19% overall in the ttfields arms and 2% overall in the control arms).

• 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: 24994945
• Report Number: 3010457505-2026-00721
• Device Sequence Number: 21303531
• Product Code: SDA
• UDI-Device Identifier: 07290107983235
• UDI-Public: (01)07290107983235(11)250206
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2026

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: 04/02/2026
• Initial Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2025
• 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: CERVEDILOL; CITALOPRAM HYDROBROMIDE; FENTANYL PATCH; FOLIC ACID; HYDROCORTISONE; LORAZEPAM; ONDANSETRON; PROBIOTIC; SENNA; TRIAZOLAM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male