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	03/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure's medical opinion is that the contribution of the transducer arrays to the skin infection cannot be ruled out.Skin infection is an expected event with optune gio device use (ef-11 0% and <1% ef-14 optune arm).
Event or Problem Description
An (b)(6) -year-old male patient with newly diagnosed glioblastoma (gbm) began optune gio therapy on (b)(6) 2025.On (b)(6) 2026, novocure received a medical record dated march 11, 2026, indicating that the patient developed painful scalp sores, including one particularly painful lesion, and temporarily discontinued optune gio therapy on (b)(6) 2026, to allow the scalp to heal.Physical examination revealed a small pustular lesion near the left temple and several superficial scalp abrasions without pustular drainage.To manage a superficial skin infection, the patient was prescribed clobetasol cream and cephalexin and was advised to remain off therapy until the scalp had healed.During a follow up appointment on (b)(6) 2026, it was noted that the scalp healed.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: 25687139
• Report Number: 3010457505-2026-00793
• Device Sequence Number: 9709979
• Product Code: NZK
• UDI-Device Identifier: 07290107986427
• UDI-Public: (01)07290107986427(11)160503
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional
• Initial Reporter Occupation: Physician
• 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
• Is the Reporter a Health Professional?: Yes
• 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: 80 YR
• Patient Sex: Male