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	05/19/2026
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).Note: the manufacturer date of the device tfh209774 is october 15, 2019; udi number is: (b)(4).
Event or Problem Description
A 68-year-old female patient with newly diagnosed glioblastoma (gbm) began optune gio therapy on (b)(6) 2025.On (b)(6) 2026, the patient¿s daughter informed novocure that the patient developed a skin infection above both ears and was prescribed sulfamethoxazole/trimethoprim which resolved the issue.Due to the infection, the patient temporarily discontinued optune gio therapy between on (b)(6) 2026.The reporter noted that in their opinion, the transducer arrays did not contribute to the event.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: 25634520
• Report Number: 3010457505-2026-00784
• Device Sequence Number: 13157218
• Product Code: NZK
• UDI-Device Identifier: 07290107986427
• UDI-Public: (01)07290107986427(11)160804
• Combination Product (Y/N): N
• 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): 06/26/2026

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: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female