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 Infection (4544)
Date of Event	04/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure medical opinion is that the contribution of the array placement to the folliculitis cannot be ruled out.Folliculitis is an expected event with optune gio device use (ef-11 0% and <1% ef-14 optune arm).
Event or Problem Description
A 58-year-old male patient with newly diagnosed glioblastoma (gbm) started optune gio therapy on (b)(6) 2025.On april 08, 2025, novocure was informed that, during a transducer array change on (b)(6) 2025, pimple-like sores approximately one centimeter in size were observed sporadically on the patient's left ear and on the posterior left side of the scalp.As a result, optune gio therapy was temporarily discontinued.On (b)(6) 2025, the patient's spouse reported that the patient had been evaluated by the healthcare provider (hcp) and diagnosed with folliculitis.The hcp prescribed doxycycline 100 mg, to be taken twice daily for seven days.The patient resumed optune gio therapy the same day.However, on (b)(6) 2025, it was reported that the prescribing physician evaluated the patient and advised discontinuing therapy again, pending a follow-up visit scheduled for on (b)(6) 2025.Attempts to contact the prescribing physician were made, although no reply 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: 21947962
• Report Number: 3010457505-2025-00498
• Device Sequence Number: 18322984
• Product Code: NZK
• UDI-Device Identifier: 07290107982207
• UDI-Public: (01)07290107982207(11)190319
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/02/2025

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: 04/09/2025
• Initial Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMLODIPINE.; DEXAMETHASONE.; DOCUSATE SODIUM.; DULOXETINE.; GLIPIZIDE.; HYDROCODONE-ACETAMINOPHEN.; LEVETIRACETAM.; METFORMIN.; ONDANSETRON.; POLYETHYLENE GLYCOL.; PROCHLORPERAZINE.; QUETIAPINE.; RIZATRIPTAN.; SULFAMETHOXAZOLE-TRIMETHOPRIM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male