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	03/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure medical opinion is that contribution of the array placement to the skin irritation cannot be ruled out.A risk factor for skin irritation in this patient includes concomitant pembrolizumab (rash, itching, skin blistering or peeling are common adverse reactions.Source: pembrolizumab prescribing information).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 ).
Event or Problem Description
A 75-year-old female patient with non-small cell lung cancer (nsclc) started optune lua therapy on (b)(6) 2025.On march 06, 2025, novocure was informed that the patient experienced a skin reaction, described as itching on her back after the second day of wearing the transducer arrays.The front of her torso reportedly remained unaffected.It was noted that the patient had applied a skin preparation and took unspecified oral antihistamines.The patient remained on optune lua therapy.Attempts to contact the prescribing physician for further details were made, but no response 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: 21705214
• Report Number: 3010457505-2025-00471
• Device Sequence Number: 9952227
• Product Code: SDA
• UDI-Device Identifier: 07290107983235
• UDI-Public: (01)07290107983235(11)211210
• 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): 03/27/2025

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: 03/06/2025
• Initial Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2021
• 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.; APIXABAN.; BUDESONIDE/FORMOTEROL.; CARVEDILOL.; FUROSEMIDE.; IPRATROPIUM BROMIDE/ALBUTEROL SULFATE.; LIDOCAINE GEL.; LOSARTAN POTASSIUM.; METHOCARBAMOL.; ONDANSETRON.; PEMBROLIZUMAB.; POTASSIUM CHLORIDE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female