MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 03/24/2022

Event Type  Injury  

Manufacturer Narrative

Novocure medical opinion is that a contribution of the array placement to the event cannot be ruled out.Medical device site reaction 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 the optune arm of the trial (53%).

Event Description

A (b)(6)-year old female patient with newly diagnosed glioblastoma (gbm) began optune therapy on (b)(6) 2020.Novocure received a report on (b)(6) 2022, that the patient reportedly experienced a skin irritation and a wound on her head.On (b)(6) 2022, it was reported that the patient had been hospitalized on an unspecified date for five days due to worsened skin irritation/wound on the forehead.No further information provided.Patient continued with optune therapy.After several attempts of contact, prescribing physician did not reply with any additional information or causality assessment.

• 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: 14114231
• MDR Text Key: 289302233
• Report Number: 3010457505-2022-00207
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 04/14/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: TFH9100
• Device Catalogue Number: TFH9100EU
• Device Lot Number: N/A
• Initial Date Manufacturer Received: 03/24/2022
• Initial Date FDA Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: NOT PROVIDED.
• Patient Outcome(s): Hospitalization
• Patient Age: 58 YR
• Patient Sex: Female