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	07/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A 75-year-old male patient with non-small cell lung cancer (nsclc) began optune lua therapy on (b)(6) 2025.On (b)(6) 2025, novocure received a medical record dated (b)(6) 2025, indicating that the patient temporarily discontinued optune lua therapy due to pruritic maculopapular rash grade 3, described as significant itchy rash on the chest and upper back.The patient was initiated on medium to high potency topical steroids.At a follow up appointment on (b)(6) 2025, it was noted that optune lua therapy had not yet resumed.However, the rash improved, with grade 1 rash remaining, localized to the central chest around the sternum and underneath the right rib cage.Mild erythema was still present.The patient had been prescribed triamcinolone acetonide 0.5% topical cream and amoxicillin 875 mg/potassium clavulanate 125mg, to be taken twice daily for fourteen days.On (b)(6) 2025, the patient informed novocure of continued skin irritation, including open areas on the torso.The patient reported that he had been prescribed unspecified antibiotics and ointment.On (b)(6) 2025, the prescribing physician reported that the patient temporarily discontinued optune lua therapy on (b)(6) 2025, due to the development of a rash, although immunotherapy was continued.The rash resolved completely by (b)(6) 2025, and optune lua therapy was resumed.However, on (b)(6) 2025, the rash recurred, prompting another therapy interruption.The patient was prescribed amoxicillin for two weeks.By (b)(6) 2025, the rash had improved but was not fully resolved.The patient was advised to apply triamcinolone cream and remain off therapy.On (b)(6) 2025, following a resumption of optune lua therapy, the rash worsened.Betamethasone cream was prescribed, and therapy was again discontinued.The prescribing physician confirmed that the rash was attributable to optune lua therapy.
Additional Manufacturer Narrative
Novocure's medical opinion is that a contribution of the transducer arrays to the skin inflammation/irritation that required medical intervention cannot be ruled out.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: 22824911
• Report Number: 3010457505-2025-00565
• Device Sequence Number: 14568707
• Product Code: SDA
• UDI-Device Identifier: 07290107983235
• UDI-Public: (01)07290107983235(11)201125
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/18/2025

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: TFT9200
• Device Catalogue Number: TFT9200US
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2020
• 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: ALBUTEROL; ATORVASTATIN; CLOPIDOGREL; DEXAMETHASONE; EZETIMIBE; LEVOTHYROXINE; LIDOCAINE-PRILOCAINE TOPICAL CREAM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 73 KG