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	04/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A 71-year-old female with recurrent glioblastoma (gbm) started optune gio therapy on (b)(6)2025.On (b)(6) 2026, novocure received a medical record dated (b)(6)2026, indicating that the patient experienced intermittent scalp irritation with small, painful sores.The patient reported having two scalp cysts removed by a dermatologist.Although the nodules appeared similar to those previously experienced, the patient's family reported improvement in the scalp condition.The patient was prescribed topical clobetasol.On (b)(6)2026, persistent scalp issues, including raised nodules and sores, were reported, particularly on the posterior and superior scalp, and were aggravated by optune gio use.Due to pain and skin breakdown, the patient temporarily discontinued optune gio therapy.Skin peeling following array removal and erythematous lesions beneath the arrays were also reported.During a follow-up visit on (b)(6) 2026, the patient attributed the scalp issues to head shaving and reported some improvement with mometasone cream; however, the bumps persisted.Continuation of optune gio therapy was advised.On (b)(6) 2026, the patient continued to experience scalp cysts.The dermatologist reportedly assessed them as non-concerning cysts; however, they remained painful, particularly when lying down.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 arrays placement to the skin inflammation/irritation 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).

• 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: 50446352
• Report Number: 3010457505-2026-00842
• Device Sequence Number: 18552879
• Product Code: NZK
• UDI-Device Identifier: 07290107986427
• UDI-Public: (01)07290107986427(11)190814
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 08/26/2026

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2019
• 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: 71 YR
• Patient Sex: Female