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	Hypersensitivity/Allergic reaction (1907)
Date of Event	04/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure medical opinion is that the contribution of the arrays to the allergic reaction cannot be ruled out.A risk factor for hypersensitivity in this patient includes concomitant ramucirumab (hypersensitivity reactions, and other dermatological issues such as rashes, erythema, and skin toxicities are listed among the most common adverse reactions source: ramucirumab prescribing information).Hypersensitivity was not reported in the pivotal ef-24 clinical trial for optune lua treatment for nsclc.Hypersensitivity has been reported approximately 395 times in the commercial program to date, 9 if which were and related to device use.One case was reported for a non- small-cell-lung cancer patient.
Event or Problem Description
A 75-year-old male patient with non-small cell lung cancer (nsclc) started optune lua therapy on (b)(6) 2025.On (b)(6) 2025, it was reported that the patient experienced skin irritation, described as blisters and burns, attributed to the use of the ite arrays.Later that same day, additional information provided by the patient's daughter indicated that the patient had an allergic reaction and was treated with oral diphenhydramine.Wet towels were also applied to the torso to help alleviate the burning sensation.Images provided showed diffuse, elevated hives accompanied by mild to moderate erythema on the front and back torso, right thigh, and left arm.On (b)(6) 2025, the patient's daughter reported an improvement in the patient's condition and stated that a healthcare provider (hcp) had prescribed oral steroids.However, on (b)(6) 2025, novocure was notified that the patient had discontinued optune lua therapy due to skin toxicity issues.Several attempts were made to contact the prescribing physician with no reply.

• 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: 21957992
• Report Number: 3010457505-2025-00503
• Device Sequence Number: 7272759
• Product Code: SDA
• UDI-Device Identifier: 07290107983235
• UDI-Public: (01)07290107983235(11)210823
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/05/2025

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: 04/11/2025
• Initial Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2021
• 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: ACETYLSALICYLIC ACID; B COMPLEX VITAMINS; BACITRACIN-POLYMYXIN TOPICAL OINTMENT; BETAMETHASONE DIPROPIONATE TOPICAL OINTMENT; CILOSTAZOL; DEXAMETHASONE; FUROSEMIDE; IBUPROFEN; LISINOPRIL-HYDROCHLOROTHIAZIDE; MUPIROCIN TOPICAL OINTMENT; PROCHLORPERAZINE; RAMUCIRUMAB; SIMVASTATIN; VARENICLINE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male