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 Codes	Hypersensitivity/Allergic reaction (1907); Skin Inflammation/ Irritation (4545)
Date of Event	07/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure's medical opinion is that a contribution of the transducer arrays to the skin inflammation/irritation and hypersensitivity 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).Hypersensitivity was not reported in the pivotal ef-24 clinical trial for optune lua treatment for nsclc.Hypersensitivity has been reported approximately 403 times in the commercial program to date, 12 were assessed as serious and related to device use.
Event or Problem Description
A 72-year-old male patient with non-small cell lung cancer (nsclc) began optune lua therapy on (b)(6) 2025.On (b)(6) 2025, the patient's spouse reported to novocure that the patient temporarily discontinued optune lua therapy from july 10 to (b)(6) 2025, due to the development of a severe blistering rash on the torso from the arrays.Additionally, the patient experienced a mild rash localized to the arms and neck, attributed to immunotherapy.The healthcare provider (hcp) prescribed 2.5% hydrocortisone cream; reportedly the patient had already been using a skin preparation product.At the time of the report, the rash persisted on the torso but had significantly improved, allowing the patient to resume optune lua therapy.On (b)(6) 2025, the spouse reported that the patient had been struggling with ongoing skin irritation since starting optune lua therapy, with a severe rash developing after three days of therapy initiation.The patient was subsequently prescribed hydrocortisone cream, diphenhydramine, and steroids.The hcp suspected the patient developed an allergic reaction to the arrays.As described in the report, the rash was painful and pruritic, with open, purulent sores located on the front and back of the torso beneath the arrays.The patient decided to permanently discontinue optune lua therapy.The prescribing physician was contacted for further details, although no reply was received.

• 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: 22882042
• Report Number: 3010457505-2025-00574
• Device Sequence Number: 21240411
• Product Code: SDA
• UDI-Device Identifier: 07290107983235
• UDI-Public: (01)07290107983235(11)210913
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 08/25/2025

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: 07/30/2025
• Initial Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2021
• 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: ALBUTEROL SULFATE.; FLUTICASONE FUROATE-VILANTEROL.; FLUTICASONE PROPIONATE-SALMETEROL.; METHYLPREDNISOLONE.; ONDANSETRON.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 74 KG