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 03/16/2024

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 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 61-year-old female with newly diagnosed glioblastoma (gbm) started optune gio therapy on (b)(6) 2024.On (b)(6) 2024, the patient´s spouse reported that the patient experienced an unwitnessed fall while holding the optune gio device in her hand.The patient hit her head and sustained a skin laceration on the back of her head.The skin laceration was treated in the emergency department (ed) with stitches.Reportedly, the treating physician noted that due to the impact of the fall, the array disk might have contributed to a larger skin laceration.The patient was advised to pause optune gio therapy for 10 days.The prescribing physician was contacted for further details without reply.

• 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: 19085910
• MDR Text Key: 339878222
• Report Number: 3010457505-2024-00269
• Device Sequence Number: 1
• Product Code: NZK
• UDI-Device Identifier: 7290107982207
• UDI-Public: (01)7290107982207(11)171013
• 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: 04/11/2024

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: TFH9100US
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/16/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/13/2017
• 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: BUTALBITAL-ACETAMINOPHEN-CAFFEINE; DEXAMETHASONE; ESCITALOPRAM; LEVETIRACETAM; LISINOPRIL; MELATONIN; ONDANSETRON; TEMOZOLOMIDE
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 69 KG