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	07/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A 62-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 reported experiencing minor skin irritation localized to the left side of the torso.Subsequently, during a home visit on (b)(6) 2025, with the patient and the patient's caregivers, it was noted that the patient had developed a fever, severe rash and worsening skin irritation during the prior week.These symptoms were suspected to be associated with the initiation of chemotherapy on (b)(6) 2025.The patient was prescribed a 10-day course of trimethoprim/sulfamethoxazole, along with nystatin and a topical numbing cream.It was also reported that the transducer arrays were coming off the torso during episodes of night sweats.One photo was provided, depicting the patient's front torso.The image revealed round, papular like lesions with moderate surrounding erythema.Two lesions were observed on the left breast, one on the mid-left abdominal quadrant, and two located adjacent to the umbilicus.Additionally, mild scattered erythema was noted throughout the torso.On (b)(6) 2025, novocure received a medical record dated (b)(6) 2025, indicating that the patient experienced night sweats and fatigue related to optune lua therapy.The patient was prescribed lidocaine/prilocaine cream for access discomfort, hydrocortisone cream for rash and trimethoprim/sulfamethoxazole for generalized rash/boils.It was noted that the patient was supposed to complete the antibiotic course on (b)(6) 2025.The prescribing physician was contacted for further details although no reply was received.
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.Fatigue and night sweats were related to the use of device, although not serious.Pyrexia was unrelated to the use of the device.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: 22824998
• Report Number: 3010457505-2025-00567
• Device Sequence Number: 11903280
• Product Code: SDA
• UDI-Device Identifier: 07290107983235
• UDI-Public: (01)07290107983235(11)211223
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: 07/25/2025
• Initial Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/23/2021
• 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: DEXAMETHASONE; HYDROCODONE-ACETAMINOPHEN; LORAZEPAM; MECLIZINE; NAPROXEN; OLANZAPINE; ONDANSETRON; PROMETHAZINE; TAMSULOSIN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male