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 11/13/2023

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 68-year-old male with newly diagnosed glioblastoma (gbm) started optune therapy on (b)(6) 2020.On (b)(6) 2023, the patient's spouse informed novocure that the patient was hospitalized on an unspecified date due to a fall related to a mobility issue, unrelated to optune therapy.As a result of the fall, the patient hit his head and sustained a skin laceration described as a "cut" that required wound care.It was confirmed by the spouse, that the transducer arrays were located at the site of the head injury.Optune therapy was temporarily discontinued.The prescribing physician did not provide a causality assessment.

• 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: 18533022
• MDR Text Key: 333086708
• Report Number: 3010457505-2023-00251
• Device Sequence Number: 1
• Product Code: NZK
• UDI-Device Identifier: 07290107982221
• UDI-Public: 07290107982221
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• 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: TFH9100US
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2019
• 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: ATORVASTATIN; CITALOPRAM; LACOSAMIDE; LEVETIRACETAM; NORTRIPTYLINE; ONDANSETRON; PHENYTOIN; TAMSULOSIN; TRIMETHOPRIM/SULFAMETHOXAZOLE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 75 KG