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	Wound Dehiscence (1154)
Date of Event	06/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A 72-year-old female patient with newly diagnosed glioblastoma (gbm) initiated optune gio therapy on (b)(6), 2023.On june 10, 2026, novocure was informed that the patient developed scalp skin irritation, described as a contusion or indentation on the side of the head.As a result, optune gio therapy was temporarily discontinued.The provided image demonstrated purulent drainage with moderate erythema at the patient¿s surgical resection site above the left ear.On june 29, 2026, the patient reported that, due to the skin irritation, she had not used the therapy from (b)(6) through (b)(6), 2026.Following resumption of optune gio therapy from (b)(6) through (b)(6), 2026, the irritation recurred.A physician prescribed topical clobetasol propionate cream, and the patient rotated the arrays in an attempt to reduce further irritation.An additional photograph of the same area demonstrated a wound dehiscence at the superior aspect of the surgical resection site, accompanied by mild erythema.On (b)(6), 2026, the patient reported upon removing the arrays that day, she observed a large sore along the surgical resection site.The patient confirmed that she had been rotating the arrays and that the healthcare provider was aware of the recurrent event.Multiple attempts were made to contact the prescribing physician; however, no response was received.
Additional Manufacturer Narrative
Novocure's medical opinion is that the contribution of the array placement to the wound dehiscence that might have led to serious deterioration in the state of patient¿s health cannot be ruled out.Wound dehiscence is an expected event with optune gio device use (ef-11 0% and <1% ef-14 optune arm).Contributing factors for wound dehiscence in this patient include: concomitant bevacizumab (vegf inhibitor which carries a black box warning for wound healing complications, source bevacizumab prescribing information), prior radiation, underlying cancer disease and prior surgery affecting skin integrity.

• 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: 50033757
• Report Number: 3010457505-2026-00816
• Device Sequence Number: 13238771
• Product Code: NZK
• UDI-Device Identifier: 07290107986427
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/27/2026

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?: No
• Initial Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2019
• 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: Other
• Patient Age: 72 YR
• Patient Sex: Female