MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number	TFH9100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	01/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A 44 year old female patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2021.During a neuro-oncology visit on (b)(6) 2022, the prescribing physician noted the patient developed a 1 cm scalp erosion near the surgical resection incision (last surgical resection on (b)(6) 2020).The patient remained on optune therapy.On (b)(6) 2022, the patient presented to neuro-oncology clinic visit, to discuss if surgical treatment for an open scalp wound is required, no further details were available at that time.Patient remained on optune therapy.On (b)(6) 2023, it was reported that due to a wound complication, the patient was scheduled for surgery on (b)(6) 2023.Optune therapy was temporarily discontinued.Per the healthcare provider the patient was planned to undergo repair of a chronic non-healing right frontal scalp wound.On (b)(6) 2023, the spouse reported a small portion of cranial bone was surgically removed on the right side of the head and the patient was still recovering.Optune therapy would be resumed once cleared by neurosurgery.No causality assessment was provided by the prescribing physician.
Additional Manufacturer Narrative
Novocure opinion is that the contribution of the array placement to wound dehiscence cannot be ruled out.Contributing factors for wound dehiscence in this patient include: prior radiation, underlying cancer disease, and prior surgery affecting skin integrity.Wound dehiscence 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/tmz arm of the trial (<1%) only.

• Brand Name: OPTUNE
• Common Device Name: 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: 16378287
• Report Number: 3010457505-2023-00226
• Device Sequence Number: 20402991
• Product Code: NZK
• UDI-Device Identifier: 07290107982221
• UDI-Public: 07290107982221
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P100034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/15/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: TFH9100
• Device Catalogue Number: TFH9100US
• Device Lot Number: N/A
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CETIRIZINE; CITALOPRAM; FLUOXETINE; LEVETIRACETAM; MELATONIN; PREDNISONE; TEMOZOLOMIDE; TRAZODONE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 67 KG