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	03/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
An 80-year-old male patient with non-small cell lung cancer (nsclc) started optune lua therapy on (b)(6) 2025.On (b)(6) 2025, novocure was informed that the patient had temporarily discontinued optune lua therapy on (b)(6) 2025, due to the development of a rash affecting the upper body, including both the back and front.The healthcare provider (hcp) prescribed unspecified medications, including an antibiotic, to treat the rash.The provided image demonstrated areas of mild erythema on the right torso.On (b)(6) 2025, the patient reported that he still experienced itching and remained off therapy.In addition, he was evaluated by a dermatologist on (b)(6) 2025, who determined that the rash was an allergic reaction to the adhesive used on the arrays.On (b)(6) 2025, it was reported that the prescribing physician recommended the use of a skin barrier film and topical corticosteroids.Additionally, following the dermatologist's consultation, oral corticosteroids were prescribed.Attempts to contact the prescribing physician for further details were made, although no response was received.
Additional Manufacturer Narrative
Novocure medical opinion is that the contribution of the transducer arrays to the allergic reaction cannot be ruled out.A risk factor for hypersensitivity in this patient includes concomitant docetaxel (hypersensitivity reactions, and other dermatological issues such as rashes, erythema, and skin toxicities are listed among the most common adverse reactions source: docetaxel 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 of which were serious and related to device use.

• 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: 21957965
• Report Number: 3010457505-2025-00495
• Device Sequence Number: 7265134
• 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,Health Professional
• 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.; ALBUTEROL.; ATORVASTATIN.; BENZONATATE.; BUDESONIDE-FORMOTEROL.; CYCLOBENZAPRINE.; DESONIDE TOPICAL OINTMENT.; DEXAMETHASONE.; DOCETAXEL.; DORZOLAMIDE-TIMOLOL.; FEXOFENADINE.; FUROSEMIDE.; LATANOPROST.; LEVOTHYROXINE.; METFORMIN.; METOPROLOL SUCCINATE.; METRONIDAZOLE.; OMEPRAZOLE.; ONDANSETRON.; SPIRONOLACTONE.; TAMSULOSIN.; TRIAMCINOLONE ACETONIDE TOPICAL OINTMENT.; VALSARTAN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male