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	10/02/2024
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).Medical device site reaction is an expected event with device use and was reported as an adverse event in the ef-23 trial of optune lua together with pemetrexed and cisplatin or carboplatin in patients with mesothelioma (66%) low-medium reaction, (5%) severe reaction.
Event or Problem Description
A 76-year-old male patient with unresectable biphasic pleural mesothelioma started optune lua therapy on (b)(6) 2024.During review of a medical record received by novocure on (b)(6) 2024, it was noted on (b)(6) 2024, that the patient experienced a rash described as large papular, vesicular erythematous lesions that were tender and burning where arrays were placed.The rash was located on the back and chest and not limited to the area of arrays but also in other regions of the body.The physician suspected immunotherapy (pembrolizumab/ ipilimumab) might contribute to the rash.Optune lua therapy was temporarily discontinued.The patient was prescribed triamcinolone ointment, oral prednisolone and hydroxyzine.On (b)(6) 2024, the rash had much improved and the physician instructed the patient to reintroduce optune lua therapy for 2-4 hours daily.The rash was stable on (b)(6) 2024, and the patient remained on optune lua therapy four hours daily.The prescribing physician was contacted for further details without reply.

• Brand Name: OPTUNE LUA
• Common Device Name: OPTUNE LUA
• Manufacturer (Section D): NOVOCURE GMBH; business village d4; park 6/platz 10; root, 6039 ; SZ 6039
• Manufacturer (Section G): NOVOCURE GMBH; business village d4; park 6/platz 10; root, 6039 ; SZ 6039
• Manufacturer Contact: sharon perez ; 180 hanover st.; portsmouth, NH 03801 ; 2077527602
• MDR Report Key: 20840974
• Report Number: 3010457505-2024-00387
• Device Sequence Number: 20842949
• Product Code: QGZ
• UDI-Device Identifier: 07290107983235
• UDI-Public: (01)07290107983235(11)201125
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/04/2024

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: 11/11/2024
• Initial Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2020
• 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: AMLODIPINE; IPILIMUMAB; LEVOTHYROXINE; LISINOPRIL; PEMBROLIZUMAB
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male