MAUDE Adverse Event Report: NOVOCURE GmbH Optune Lua NSCLC

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	06/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A 61-year-old female patient with non-small cell lung cancer (nsclc) began optune lua therapy on (b)(6) 2025.On july 01, 2026, novocure received a medical record dated june 11, 2026, indicating that the patient experienced significant pruritus and skin irritation.The symptoms were managed with unspecified topical agents and oral hydroxyzine.The patient reported using optune lua therapy for 12 to 15 hours per day; however, due to worsening nocturnal pruritus, she adjusted her device usage schedule to minimize sleep disturbances.The patient was advised to moisturize the affected skin regularly and avoid sun exposure.Additionally, the healthcare provider recommended oral diphenhydramine at bedtime if the pruritus worsened.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.Sleep disturbance was secondary to pruritus therefore not coded separately.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 NSCLC
• Common Device Name: Optune Lua
• Manufacturer (Section D): NOVOCURE GmbH
• Manufacturer Contact: sharon perez ; 180 hanover street; portsmouth, NH ; +1(207)752-7602
• MDR Report Key: 50032841
• Report Number: 3010457505-2026-00817
• Device Sequence Number: 10408832
• Product Code: SDA
• UDI-Device Identifier: 07290107983235
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/27/2026

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
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female