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 Codes	Cellulitis (1768); Skin Inflammation/ Irritation (4545)
Date of Event	03/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A 50-year-old male patient with newly diagnosed glioblastoma (gbm) began optune gio therapy on (b)(6) 2024.On march 26, 2025, novocure received a medical record dated (b)(6) 2025, documenting that the patient experienced contact dermatitis related to optune gio therapy and was treated with a course of antibiotics due to potential cellulitis.The patient was advised to continue with optune gio therapy along with a topical steroid to reduce skin toxicity.Additional recommendations included the application of baby mineral oil to facilitate array removal and to apply silver sulfadiazine cream to nonhealing areas.Attempts to contact the prescribing physician were made, although no reply was received.
Additional Manufacturer Narrative
Novocure's medical opinion is that a contribution of the transducer arrays to the contact dermatitis and cellulitis that required medical intervention cannot be ruled out.Dermatitis contact is an expected event with optune gio device use (ef-11 0% and 1% ef-14 optune arm).Cellulitis is an expected event with optune gio device use (ef-11 0% and 1% ef-14 optune arm).

• Brand Name: OPTUNE GIO
• Common Device Name: OPTUNE GIO
• Manufacturer (Section D): NOVOCURE GMBH; neuhofstrasse 21; baar, 6340 ; SZ 6340
• Manufacturer (Section G): NOVOCURE GMBH; neuhofstrasse 21; baar, 6340 ; SZ 6340
• Manufacturer Contact: sharon perez ; 180 hanover st.; portsmouth, NH 03801 ; 2077527602
• MDR Report Key: 21855248
• Report Number: 3010457505-2025-00484
• Device Sequence Number: 17323740
• Product Code: NZK
• UDI-Device Identifier: 07290107982207
• UDI-Public: (01)07290107982207(11)160510
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P100034
• 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): 04/17/2025

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DOCUSATE SODIUM; FEXOFENADINE; LEVETIRACETAM; ONDANSETRON; PARACETAMOL; PREGABALIN; TEMOZOLOMIDE; VALACYCLOVIR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 103 KG