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 Codes	Skin Infection (4544); Skin Inflammation/ Irritation (4545)
Date of Event	06/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure's medical opinion is that the contribution of the transducer arrays to the skin inflammation/irritation and skin infection requiring medical intervention 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).Skin infection is an expected event with optune gio device use (ef-11 0% and <1% ef-14 optune arm).
Event or Problem Description
A 52-year-old male with newly diagnosed glioblastoma (gbm) started optune gio (b)(6) 2025.On (b)(6) 2026, the patient informed novocure that he experienced redness and open sores on the scalp.The patient was prescribed a ten-day course of oral cephalexin and advised to temporarily discontinue optune gio therapy.In an available medical record, during a neuro-oncology follow up visit on (b)(6) 2026, the physician documented that the patient had an open wound and scalp irritation, with drainage secondary to optune device use.The physician prescribed cephalexin 500mg four times daily for ten days multiple attempts were made to contact the prescribing physician; however, no reply was received.

• Brand Name: OPTUNE GIO
• Common Device Name: OPTUNE GIO
• Manufacturer (Section D): NOVOCURE GMBH
• Manufacturer Contact: sharon perez ; 180 hanover street; portsmouth, NH ; 2077527602
• MDR Report Key: 25687272
• Report Number: 3010457505-2026-00798
• Device Sequence Number: 13189289
• Product Code: NZK
• UDI-Device Identifier: 07290107986427
• UDI-Public: (01)07290107986427(11)191209
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100034/S033
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2026

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
• Device Lot Number: N/A
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male