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	02/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure medical opinion is that the contribution of the transducer arrays to the skin inflammation/irritation on the head 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).
Event or Problem Description
A 48-year-old male patient with newly diagnosed glioblastoma (gbm) started optune gio therapy on (b)(6) 2019.During review of medical records received by novocure on (b)(6) 2025, it was noted that during an oncology appointment on (b)(6) 2025, the patient experienced a skin reaction described as redness and pustules, without any visible breakdown or ulceration while on optune gio therapy.The patient was reported to be taking unspecified oral antihistamines.On (b)(6) 2025, novocure was notified that the patient developed two areas of very red, raw spots near the surgical resection scar, which were beginning to scab over.An image provided depicted two wounds on the surgical resection scar, with mild erythema and yellow tinged exudate.As a result, optune gio therapy was temporarily discontinued.Attempts to contact the prescribing physician for further details were made, but no response was received.

• 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: 21675423
• Report Number: 3010457505-2025-00472
• Device Sequence Number: 18200475
• Product Code: NZK
• UDI-Device Identifier: 07290107982207
• UDI-Public: (01)07290107982207(11)170716
• Combination Product (Y/N): N
• 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: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/24/2025

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: 02/28/2025
• Initial Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: APIXABAN.; DEXAMETHASONE.; FLUOXETINE.; LACOSAMIDE.; LEVETIRACETAM.; METFORMIN.; MIDAZOLAM.; MIRABEGRON.; OLANZAPINE.; PANTOPRAZOLE.; VALPROATE SODIUM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 109 KG