FDA Adverse Event Injury Summary report: N

OPTUNE GIO

MDR report key: 22564404 · Received July 22, 2025

Report

Report Number: 3010457505-2025-00543
Event Type: Injury
Date Received: July 22, 2025
Date of Event: July 2, 2025
Report Date: July 22, 2025
Manufacturer: NOVOCURE GMBH
Product Code: NZK
UDI-DI: 07290107986328
PMA / PMN Number: P100034
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

NOVOCURE'S MEDICAL OPINION IS THAT A CONTRIBUTION OF THE TRANSDUCER ARRAYS TO THE SKIN INFLAMMATION/IRRITATION THAT REQUIRED SURGICAL 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). THE DERMAL CYST WAS NOT RELATED TO OPTUNE GIO THERAPY.

Description of Event or Problem · 0

A 58-YEAR-OLD FEMALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT INFORMED NOVOCURE THAT SHE HAD UNDERGONE SURGERY EARLIER THAT DAY TO REMOVE AN ATHEROMA FROM HER SCALP. OPTUNE GIO THERAPY WAS TEMPORARILY DISCONTINUED. ON (B)(6) 2025, THE PATIENT'S PRESCRIBING PHYSICIAN CONFIRMED THAT THE PROCEDURE TO REMOVE THE PRE-EXISTING ATHEROMA WAS CONDUCTED ON AN OUTPATIENT BASIS. THE PHYSICIAN INDICATED THAT THE ATHEROMA MAY HAVE BECOME SORE BECAUSE OF HEAT EXPOSURE AND CONCURRENT USE OF OPTUNE GIO THERAPY. HOWEVER, IT WAS NOT CONSIDERED INFLAMED. A FAMILY HISTORY OF THIS CONDITION WAS ALSO NOTED. THE PATIENT PLANNED TO RESUME OPTUNE GIO THERAPY ONCE THE STITCHES ARE REMOVED AND THE WOUND HAS HEALED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2293780	OPTUNE GIO	OPTUNE GIO	NZK	NOVOCURE GMBH	TFH9100		07290107986328

Patients

Seq	Age	Sex	Outcome	Treatment
1	58 YR	Female	Required Intervention	DEXAMETHASONE\| IBUPROFEN\| PANTOPRAZOLE