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	Cellulitis (1768)
Date of Event	08/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure's medical opinion is that the contribution of the array placement to the cellulitis cannot be ruled out.Cellulitis is an expected event with optune gio device use (ef-11 0% and 1% ef-14 optune arm).
Event or Problem Description
A 47-year-old male with newly diagnosed glioblastoma (gbm) started optune gio (b)(6) 2024.On (b)(6) 2025, the patient's caregiver informed novocure that the patient experienced cellulitis and sent photos to the oncologist, who advised temporarily discontinuing optune gio therapy.The caregiver planned to contact the primary care physician to request a stronger unspecified antibiotic prescription.On (b)(6) 2025, the caregiver confirmed that cellulitis persisted and another 10-day course of antibiotics was initiated.By on (b)(6) 2025, a third round of antibiotics was required, with approximately one week of treatment remaining, although the condition appeared to be improving.On (b)(6) 2025, the caregiver stated that the antibiotic course had been completed, but cellulitis had recurred.On (b)(6) 2025, the caregiver confirmed that treatment had not resumed, as the dermatologist prescribed three additional unspecified medications.The patient would not resume optune gio until the scalp was completely healed.On november 03, 2025, novocure received a medical record dated on (b)(6) 2025, which confirmed previous findings of scalp irritation and wounds requiring antibiotics, with optune gio temporarily discontinued on (b)(6) 2025.On (b)(6) 2025, the caregiver reported that an attempt to resume treatment the previous week was unsuccessful due to persistent irritation on the top and sides of the scalp.Multiple attempts were made to contact the prescribing physician, although no reply 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: 23618067
• Report Number: 3010457505-2025-00624
• Device Sequence Number: 15697492
• Product Code: NZK
• UDI-Device Identifier: 07290107982207
• UDI-Public: (01)07290107982207(11)170105
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 11/21/2025

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: 08/11/2025
• Initial Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/05/2017
• 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: CLONAZEPAM.; DEXAMETHASONE.; LACOSAMIDE.; LAMOTRIGINE.; LEVETIRACETAM.; MELOXICAM.; MUPIROCIN.; ONDANSETRON.; PROPRANOLOL.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 127 KG