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 Infection (4544)
Date of Event	06/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure medical opinion is that a contribution of the transducer arrays to the folliculitis cannot be ruled out.Folliculitis is an expected event with optune gio device use (ef-11 0% and <1% ef-14 optune arm).
Event or Problem Description
A 46-year-old male patient with newly diagnosed glioblastoma (gbm) started optune gio therapy on (b)(6) 2024.On (b)(6) 2025, the patient reported to novocure that he had developed a significant reaction to one of his daily chemotherapy medications, presenting as pustules across the entire scalp.A medical record received by novocure on june 13, 2025, referenced a neuro-oncology appointment on (b)(6) 2025, during which the patient was noted to have scalp irritation characterized by erythema and a few crusted sores due to optune gio therapy and reportedly was using an unspecified topical steroid cream.At a follow up appointment on (b)(6) 2025, the patient was diagnosed with folliculitis and prescribed doxycycline 100mg orally once daily.Images provided showed diffuse, scattered pustules across the scalp with mild to moderate erythema.One image revealed a small region of crusted exudate with moderate erythema.Optune gio therapy was temporarily discontinued.Attempts to contact the prescribing physician for further details were made, but no response was received.

• 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: 22409648
• Report Number: 3010457505-2025-00538
• Device Sequence Number: 9796111
• Product Code: NZK
• UDI-Device Identifier: 07290107982207
• UDI-Public: (01)07290107982207(11)160823
• Combination Product (Y/N): N
• 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: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/07/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2016
• 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: APIXABAN; CHOLESTYRAMINE; DEXAMETHASONE; ETOPOSIDE; FLUOXETINE; GABAPENTIN; GABAPENTIN; LEVETIRACETAM; ONDANSETRON; OSIMERTINIB MESYLATE; WARFARIN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male