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	02/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A 68-year-old male patient with newly diagnosed glioblastoma (gbm) started optune gio therapy on (b)(6) 2024.During the review of the patient's medical records received by novocure on january 29, 2025, it was noted that the patient had experienced significant scalp irritation, minimal itching, and a mild rash related to optune gio therapy.Additional medical records received on april 01, 2025, documented a neuro-oncology clinic visit on (b)(6) 2025, during which the patient reported skin irritation and scalp pruritus attributed to ongoing optune gio therapy.The patient managed the discomfort by tapping his head to alleviate and prevent the itching.To address the pruritus, the patient was prescribed gabapentin 300 mg each morning for three days.If no improvement was observed, hydroxyzine hcl 10 mg, three times daily as needed, was recommended as an alternative.The patient remained on optune gio therapy.Attempts to contact the prescribing physician were made, although no reply was received.
Additional Manufacturer Narrative
Novocure opinion is that the contribution of the transducer arrays to the skin irritation that required 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; 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: 21906637
• Report Number: 3010457505-2025-00493
• Device Sequence Number: 20988387
• Product Code: NZK
• UDI-Device Identifier: 07290107982207
• UDI-Public: (01)07290107982207(11)160713
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/25/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2016
• 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: ACETYLSALICYLIC ACID.; ALPRAZOLAM.; AMLODIPINE.; ATORVASTATIN.; CLINDAMYCIN TOPICAL.; DIPHENHYDRAMINE-ZINC ACETATE TOPICAL.; ENALAPRIL.; FLECAINIDE.; FLUOXETINE.; LEVETIRACETAM.; NADOLOL.; ONDANSETRON.; POLYETHYLENE GLYCOL.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male