MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE GIO

Model Number TFH9100

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

Patient Problems Fall (1848); Laceration(s) (1946)

Event Date 02/13/2024

Event Type  Injury  

Manufacturer Narrative

Novocure medical opinion is that a contribution of the device use to the fall and to the secondary reported skin laceration cannot be excluded.Fall is an expected event with optune gio device use (ef-11 4% and 8% ef-14 optune arm).Skin laceration is an expected event with optune gio device use (ef-11 0% and 1% ef-14 optune arm).

Event Description

An 85-year-old female with newly diagnosed glioblastoma (gbm) started optune gio therapy on (b)(6) 2022.On (b)(6) 2024, the patient reported that she fell the day prior when she wanted to cross the street, sustaining a 3 cm long occipital skin laceration on her head.The patient mentioned she fell over the device backpack.Following the fall, the patient was taken to the emergency room (er) by ambulance.In the er, the patient was not able to remember the fall.The occipital head wound was closed using medical glue.Head ct was performed and no further injuries were detected.The patient was discharged to home on the same day.The prescribing physician did confirm that the patient sustained a skin laceration, which required treatment.He did not provide a causality on the event.

• 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: 18902315
• MDR Text Key: 337636177
• Report Number: 3010457505-2024-00262
• Device Sequence Number: 1
• Product Code: NZK
• UDI-Device Identifier: 07290107981194
• UDI-Public: (01)07290107981194(11)200323
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/23/2020
• 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: ACETYLSALICYLIC ACID; ATORVASTATINE; DOXYCYCLINE; MEBENDAZOLE; METFORMIN
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female