MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE PAX; Low Electric Field Generator For Pancreatic Cancer Treatment

Model Number	TFP9200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Itching Sensation (1943)
Date of Event	06/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure's medical opinion is that the contribution of the transducer arrays to the pruritus requiring medical intervention cannot be ruled out.The acrochordons (skin tags) were not related to device use.Pruritus was reported in the pivotal ef-27 clinical trial for optune pax treatment for locally advanced pancreatic cancer (22.3% in the ttfields arm and 8.4% in the control arm).
Event or Problem Description
An 85-year-old male with pancreatic adenocarcinoma started optune pax therapy (b)(6) 2026.On (b)(6) 2026, the patient reported to novocure the presence of two skin tags on his back that occasionally became itchy due to contact with the transducer arrays.The patient was prescribed an unspecified oral medication to alleviate the itching associated with skin tags.Multiple attempts were made to contact the prescribing physician; however, no reply was received.

• Brand Name: OPTUNE PAX
• Common Device Name: Low Electric Field Generator For Pancreatic Cancer Treatment
• Manufacturer (Section D): NOVOCURE GMBH
• Manufacturer Contact: sharon perez ; 180 hanover street; portsmouth, NH ; 2077527602
• MDR Report Key: 25687280
• Report Number: 3010457505-2026-00799
• Device Sequence Number: 17307582
• Product Code: SHC
• UDI-Device Identifier: 07290107987509
• UDI-Public: (01)07290107987509(11)260226
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P250034/S001
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2026

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: TFP9200
• Device Catalogue Number: TFP9200US
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 07/02/2026
• Supplement Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male