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	08/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A 63-year-old female with newly diagnosed glioblastoma (gbm) started optune gio therapy on (b)(6), 2026.On august 21, 2026, novocure received a medical record dated august 17, 2026, indicating that the patient experienced scalp irritation and itching and was prescribed hydroxyzine.The medication was also recommended to use for nighttime anxiety related to potential progression of underlying disease.On (b)(6), 2026, the prescribing physician confirmed that the patient experienced skin irritation related to optune gio arrays.The patient was treated with hydroxyzine, which resolved the event, and continued optune gio therapy.According to the physician, the patient was not taking any medications that could have been considered a risk factor for skin irritation.
Additional Manufacturer Narrative
Novocure's medical opinion is that the contribution of the transducer arrays placement to the skin inflammation/irritation requiring medical intervention cannot be ruled out.Anxiety is unrelated to device use.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
• Manufacturer Contact: sharon perez ; 180 hanover street; portsmouth, NH ; +1(207)752-7602
• MDR Report Key: 50767449
• Report Number: 3010457505-2026-00858
• Device Sequence Number: 18428953
• Product Code: NZK
• UDI-Device Identifier: 07290107986427
• UDI-Public: (01)07290107986427(11)170913
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 09/15/2026

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
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female