MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Infection (4544)

Event Date 02/14/2023

Event Type  Injury  

Manufacturer Narrative

Novocure opinion is that the contribution of the array placement to erysipelas cannot be ruled out.Skin infection in general is an expected event with device use and was reported as an adverse event in the ef-14 trial of optune together with temozolomide (tmz) compared to tmz alone in patients with newly diagnosed gbm in both arms of the trial (<1% and <1% in optune/tmz and tmz arms respectively).

Event Description

A 49-year old male patient with astrocytoma, who grade iv, started optune therapy on (b)(6) 2023.On (b)(6) 2023, the patient's spouse reported the patient was hospitalized on february 15, 2023, due to a head infection.Optune therapy was temporarily discontinued on (b)(6) 2023.The prescribing physician reported on (b)(6) 2023, the patient had a right temporal, erysipelas with redness, swelling and signs of infection on the scalp with fever and chills.Patient received unspecified intravenous antibiotic treatment.On (b)(6) 2023, during a follow up outpatient appointment, no irritation, redness or swelling was observed.On (b)(6), 2023, patient reported he discontinued optune therapy.The prescribing physician assessed the event as related to optune therapy.

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• Manufacturer (Section D): NOVOCURE GMBH; business village d4; park 6/platz 10; root d4, 6039 ; SZ 6039
• Manufacturer (Section G): NOVOCURE GMBH; business village d4; park 6/platz 10; root d4, 6039 ; SZ 6039
• Manufacturer Contact: sharon perez ; 195 commerce way; portsmouth, NH 03801 ; 2077527602
• MDR Report Key: 16544820
• MDR Text Key: 311303936
• Report Number: 3010457505-2023-00229
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P100034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: TFH9100
• Device Catalogue Number: TFH9100EU
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TEMOZOLOMIDE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male