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	Cellulitis (1768); Ulcer (2274)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure's medical opinion is that the contribution of the array placement to cellulitis and the ulcerations cannot be ruled out.Cellulitis was not reported as an adverse event in the ef-23 trial of optune lua together with pemetrexed and cisplatin or carboplatin in patients with mesothelioma.There have been 83 reports of cellulitis in the optune commercial program to date and 0 cases for pleural mesothelioma.Medical device site ulcer was not reported as an adverse event in the ef-23 trial of optune lua together with pemetrexed and cisplatin or carboplatin in patients with mesothelioma.There have been 316 reports of medical device site ulcer in the optune commercial program to date and 0 cases for pleural mesothelioma.
Event or Problem Description
An 83-year-old female with malignant pleural mesothelioma (mpm) initiated optune lua therapy on (b)(6) 2025.On (b)(6) 2025, novocure received a medical record indicating that during an appointment with radiation oncology on (b)(6) 2025, the patient reported significant skin irritation, increased sensitivity, and a sensation of skin "ripping" attributed to the use of the optune lua device.The patient was prescribed clobetasol ointment, which caused a burning sensation upon application.The patient temporarily discontinued optune lua therapy.During an appointment on (b)(6) 2025, it was documented that the patient had a history of delayed wound healing on the left chest wall, secondary to optune lua use.The patient had applied clobetasol, mometasone, and silver sulfadiazine ointments without clinical improvement.The patient had discontinued optune lua over one month prior due to grade 2 dermatitis.Over the two weeks preceding the appointment, the patient experienced progressive erythema, swelling, and pain involving the left breast, axilla, and chest wall.Clinical examination revealed moderate erythema, warmth, tenderness, and skin induration, most pronounced in the left inferior axilla.Additionally, two dry, healing ulcerations with scabbed formation were observed on the left upper scapular region.The health care provider (hcp) diagnosed the condition as cellulitis, likely originating from the area of ulceration on the posterior lateral back, accompanied by left shoulder pain.The hcp prescribed a 7-day course of an unspecified antibiotic for treatment.Multiple attempts were made to contact the prescribing physician for clarification; however, no response was received.
Additional Manufacturer Narrative
On january 23, 2026, novocure received additional information from the prescribing physician.The physician reported that the patient had not been hospitalized and had received treatment with an unspecified oral antibiotic.Fair skin was reported as the sole risk factor.The physician assessed the events as related to optune lua therapy.Furthermore, it was reported that the patient had died on (b)(6) 2026; the physician attributed the death to the underlying disease and unrelated to optune lua therapy.

• 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: 24177929
• Report Number: 3010457505-2026-00669
• Device Sequence Number: 13150979
• Product Code: QGZ
• UDI-Device Identifier: 07290107983129
• UDI-Public: (01)07290107983129(11)210913
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: H180002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2026

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 02/05/2026
• 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: ALENDRONATE; APIXABAN; ATORVASTATIN; BRINZOLAMIDE; CHOLECALCIFEROL; EZETIMIBE; GABAPENTIN; LATANOPROST OPHTHALMIC SOLUTION; LEVOTHYROXINE; METOPROLOL SUCCINATE; ONDANSETRON; TIMOLOL MALEATE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female