MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE GIO

Model Number TFH9100

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

Patient Problem Laceration(s) (1946)

Event Date 01/14/2023

Event Type  Injury  

Manufacturer Narrative

Novocure's medical opinion is that the contribution of the transducer arrays to the skin laceration cannot be ruled out.The fall was unrelated to device use.Skin laceration 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 58-year-old male with newly diagnosed glioblastoma (gbm) started optune gio therapy on (b)(6) 2023.On (b)(6) 2024, novocure was informed by the spouse that the patient fell the prior day and sustained a skin laceration on his head from the ine arrays.The patient subsequently went to the emergency department (er), where the laceration on his head was closed with 7 stitches.Optune gio therapy was temporarily discontinued since (b)(6) 2024.On (b)(6) 2024, the patient informed novocure, he had been hospitalized since a few days due to several falls.Reportedly, the healthcare provider (hcp) suspected meningitis, and a lumbar puncture was done that morning.The prescribing physician assessed that there was no relationship between the fall and optune gio.

• Brand Name: OPTUNE GIO
• Type of Device: OPTUNE GIO
• 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: 18674220
• MDR Text Key: 334949142
• Report Number: 3010457505-2024-00257
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P100034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/08/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male