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	06/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A 62-year-old male patient with non-small cell lung cancer (nsclc) started optune lua therapy on (b)(6) 2025.During a review of a medical record received by novocure, on (b)(6) 2025, it was noted during an oncology and hematology follow up appointment on (b)(6) 2025, that the patient developed a grade ii pruritic rash on the chest, attributed to optune lua therapy.The patient was prescribed hydroxyzine hcl 25mg twice daily as needed, and topical corticosteroids.Following the initiation of the treatment, the pruritus associated with the skin reaction reportedly improved.The physician recommended continuing with the skin care regimen.Attempts to contact the prescribing physician for further details were made, but no response was received.
Additional Manufacturer Narrative
Novocure medical opinion is that the contribution of the arrays to the skin irritation and pruritus which 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: 22661609
• Report Number: 3010457505-2025-00552
• Device Sequence Number: 3678152
• Product Code: SDA
• UDI-Device Identifier: 07290107983235
• UDI-Public: (01)07290107983235(11)250115
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/30/2025

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: 07/09/2025
• Initial Report FDA Received Date: 07/30/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENOSUMAB.; DEXAMETHASONE.; DOCETAXEL.; ENTECAVIR.; FINASTERIDE.; FLUCONAZOLE TOPICAL OINTMENT.; FLUCONAZOLE.; GABAPENTIN.; LOPERAMIDE.; METFORMIN.; PEMBROLIZUMAB.; SENNA.; TAMSULOSIN.; VALACYCLOVIR.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male