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	06/21/2024
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 pemetrexed (rash, pruritus, alopecia and urticaria are common adverse reactions.Source: pemetrexed 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.Insomnia is related to optune lua therapy, although not serious.
Event or Problem Description
An 85-year-old male patient with biphasic pleural mesothelioma started optune lua therapy on (b)(6) 2022.During review of the patient's medical records, received by novocure on july 30, 2024, it was noted on (b)(6) 2024, the patient developed localized skin irritation, characterized by itching and a rash originating from hair follicles, secondary to optune lua therapy.The patient was subsequently evaluated by a dermatologist and treated with hydroxyzine and diphenhydramine to alleviate the itching.On november 21, 2024, the patient informed novocure that he has been suffering from itching for two years, which made it difficult for him to fall asleep.Reportedly, the patient tried many over-the-counter ointments, was seen by a dermatologist and was changing the arrays 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: 20783796
• Report Number: 3010457505-2024-00394
• Device Sequence Number: 17406428
• Product Code: QGZ
• UDI-Device Identifier: 07290107983235
• UDI-Public: (01)07290107983235(11)210518
• Combination Product (Y/N): N
• 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): 11/26/2024

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: 07/30/2024
• Initial Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/18/2021
• 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; ALLOPURINOL; CANDESARTAN; CARVEDILOL; CETIRIZINE; EMPAGLIFLOZIN; ETHYL EICOSAPENTAENOIC ACID; FOLIC ACID; GABAPENTIN; GLIPIZIDE; MONTELUKAST; PEMETREXED; ROSUVASTATIN; SACUBITRIL/VALSARTAN; SILDENAFIL; TORSEMIDE; TRAZODONE; TRAZODONE; VITAMIN B-12
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male