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	03/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A 36-year-old male patient with newly diagnosed glioblastoma (gbm) started optune gio therapy on (b)(6) 2023.On (b)(6) 2026, novocure received a medical record dated (b)(6) 2026, reporting that the patient experienced significant skin changes noted after removal of the transducer arrays.Physical examination revealed several areas of skin breakdown with minimal erythema and scabbing, measuring less than 5 mm, and one most significant lesion measuring approximately 1-2 cm.The patient was advised to temporarily discontinue optune gio therapy and to cleanse the affected areas using the least traumatic method possible.During a subsequent appointment on (b)(6) 2026, improvement of the skin lesions compared to the previous week was noted; however, the lesions persisted.At a follow-up visit on (b)(6) 2026, the patient remained on a therapy break, and the lesions continued to be scabbed.An attempt to debride the residual lesion with minimal trauma was unsuccessful, although surrounding lesions were noted to be nearly healed.Referral to a wound clinic for further management and treatment was recommended.On (b)(6) 2026, novocure was informed that the patient remained off optune gio therapy.Multiple attempts were made to contact the prescribing physician; however, no reply was received.
Additional Manufacturer Narrative
Novocure's medical opinion is that the contribution of the transducer array placement to the skin inflammation/irritation, cannot be ruled out.Medical device site reaction is an expected event with optune gio device use (ef-11 16% and 53% 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: 24949512
• Report Number: 3010457505-2026-00723
• Device Sequence Number: 10039284
• Product Code: NZK
• UDI-Device Identifier: 07290107982207
• UDI-Public: (01)07290107982207(11)200825
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/22/2026

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: 04/03/2026
• Initial Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2026
• 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: BUDESONIDE-FORMOTEROL.; CETIRIZINE.; DEXAMETHASONE.; LEVETIRACETAM.; ONDANSETRON.; PANTOPRAZOLE.; RIVAROXABAN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male