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 Codes	Fall (1848); Laceration(s) (1946)
Date of Event	09/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure's medical opinion is that the contribution of optune device to the fall and the secondary skin laceration cannot be ruled out.Fall 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 (8% and 3% in optune/tmz and tmz arms respectively).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 or Problem Description
A 61-year-old female with newly diagnosed glioblastoma (gbm) started optune therapy on (b)(6), 2023.Novocure was informed by the patient's spouse on (b)(6), 2023, that the patient fell on (b)(6), 2023, and sustained a skin laceration on the upper right side of the scalp near the surgical resection scar that required several sutures.On (b)(6), 2023, it was confirmed that the patient was on optune therapy at the time of the fall.The patient tripped and fell forward onto the floor, and the array cords got caught in the door handle as she was falling.The patient was brought to the hospital emergency room (er) for the treatment of the skin laceration.A computed tomography (ct) scan done in the er showed a hematoma and swelling under the skin in the location of the laceration that subsided after being discharged home.Optune therapy was temporarily discontinued.The prescribing physician did not provide a causality assessment.

• 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: 17994731
• Report Number: 3010457505-2023-00248
• Device Sequence Number: 6726145
• Product Code: NZK
• UDI-Device Identifier: 07290107982221
• UDI-Public: 07290107982221
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/24/2023

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2023
• Initial Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2016
• 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: ONDANSETRON
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female