MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE GIO

Model Number	TFH9100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	11/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A 65-year-old female patient with newly diagnosed glioblastoma (gbm) started optune gio therapy on (b)(6) 2024.On (b)(6) 2025, a medical record dated on (b)(6) 2024, was received by novocure, documenting that the patient developed contact dermatitis associated with optune gio therapy, described as burning and persistent pruritus.Management included oral hydroxyzine 12.5 mg nightly, cetirizine 20 mg twice daily, clobetasol foam, mupirocin 2% ointment, and triamcinolone 0.1% ointment.At a follow-up on (b)(6) 2025, the patient reported improvement with clobetasol foam, and clinical examination showed reduced redness and resolution of erythematous papules on the scalp.Mupirocin was discontinued due to the absence of open lesions; other treatments were continued.However, during a subsequent visit on (b)(6) 2025, the patient reported ongoing symptoms, including burning and itching of the scalp.The physician's examination revealed erythematous, scaly, and crusted plaques.The physician advised restarting mupirocin 2% ointment twice daily for open lesions, continuing clobetasol (foam or ointment), initiating daily hypochlorous acid spray, and maintaining use of cetirizine and hydroxyzine.The physician also discussed the potential addition of the following treatments should current measures prove ineffective: low-dose naltrexone for scalp pain, gabapentin, and prednisone 10 mg daily.A bacterial swab was obtained during the visit; results were pending at the time of documentation.Attempts to contact the prescribing physician were made, although no reply was received.
Additional Manufacturer Narrative
Novocure's medical opinion is that a contribution of the transducer arrays to the contact dermatitis that required medical intervention cannot be ruled out.Dermatitis contact is an expected event with optune gio device use (ef-11 0% and 1% ef-14 optune arm).

• Brand Name: OPTUNE GIO
• Common Device Name: OPTUNE GIO
• 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: 22076754
• Report Number: 3010457505-2025-00517
• Device Sequence Number: 8766365
• Product Code: NZK
• UDI-Device Identifier: 07290107982207
• UDI-Public: (01)07290107982207(11)201007
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100034
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/23/2025

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: TFH9100
• Device Catalogue Number: TFH9100US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2020
• 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: ALBUTEROL.; APREPITANT.; ESTRADIOL.; EZETIMIBE.; FAMOTIDINE.; LEVETIRACETAM.; MELATONIN.; METOPROLOL.; ONDANSETRON.; PITAVASTATIN CALCIUM.; TEMOZOLOMIDE.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Female