FDA Adverse Event Injury Summary report: N

OPTUNE GIO

MDR report key: 21205725 · Received January 22, 2025

Report

Report Number: 3010457505-2025-00424
Event Type: Injury
Date Received: January 22, 2025
Date of Event: December 30, 2024
Report Date: January 22, 2025
Manufacturer: NOVOCURE GMBH
Product Code: NZK
UDI-DI: 07290107986328
PMA / PMN Number: P100034
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

NOVOCURE'S MEDICAL OPINION IS THAT THE CONTRIBUTION OF THE ARRAY PLACEMENT TO THE SKIN IRRITATION 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).

Description of Event or Problem · 0

A 68-YEAR-OLD FEMALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6), 2024. ON (B)(6) 2024, THE PATIENT REPORTED EXPERIENCING A SKIN REACTION, INCLUDING REDNESS AND ITCHING, BEGINNING IN EARLY (B)(6) 2024. DESPITE THESE SYMPTOMS, THE PATIENT CONTINUED OPTUNE GIO THERAPY. IN RESPONSE, THE PHYSICIAN PRESCRIBED BILASTINE 20 MG AND BETAMETHASONE DIPROPIONATE CREAM. A FOLLOW UP APPOINTMENT WAS SCHEDULED WITH THE PHYSICAN, AND OPTUNE GIO THERAPY WAS TEMPORARILY DISCONTINUED. ON (B)(6), 2025, THE PRESCRIBING PHYSICIAN CONFIRMED THAT THE PATIENT HAD NOT BEEN HOSPITALIZED. TREATMENT CONSISTED OF EMOLLIENTS AND DERMOCORTICOIDS. THE PHYSICIAN ATTRIBUTED THE SKIN REACTION TO THE INTENSIVE USE OF OPTUNE GIO THERAPY OVER THE PRECEDING SIX MONTHS. HOWEVER, THE PHYSICIAN NOTED THAT THE PATIENT RESUMED OPTUNE GIO THERAPY ONCE THE IRRITATION RESOLVED, WHICH OCCURRED IN LESS THAN A WEEK.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
791447	OPTUNE GIO	OPTUNE GIO	NZK	NOVOCURE GMBH	TFH9100		07290107986328

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR	Female	Required Intervention