MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE PAX

Model Number	TFP9200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Laceration(s) (1946); Blister (4537); Skin Inflammation/ Irritation (4545)
Date of Event	05/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure medical opinion is that the contribution of the transducer arrays to the skin inflammation/irritation, skin tears and blister requiring medical intervention cannot be ruled out.Skin irritation was reported in the pivotal ef-27 clinical trial for optune pax treatment for locally advanced pancreatic cancer (9.1% in the ttfields arm and 0.4% in the control arm).Blister was reported in the pivotal ef-27 clinical trial for optune pax treatment for locally advanced pancreatic cancer (3.6% in the ttfields arm and 0% in the control arm).Skin injury was reported in the pivotal ef-27 clinical trial for optune pax treatment for locally advanced pancreatic cancer (3.6% in the ttfields arm and 1.8% in the control arm).
Event or Problem Description
A 78-year-old female with pancreatic adenocarcinoma started optune pax therapy on (b)(6) 2026.On (b)(6) 2026, the patient informed novocure of experiencing skin irritation and blistering involving the abdomen, bilateral sides, and back.It was noted, several areas appeared to have superficial skin removal associated with array removal, while other areas presented with blistering.The healthcare provider prescribed an unspecified medication for the condition and temporarily discontinued optune pax therapy.The patient expressed concern that she was unable to reapply the arrays due to the current level of skin irritation.The patient planned to cut small slits in the arrays to improve flexibility and reduce tightness during future application.Images provided demonstrated two moderately erythematous longitudinal skin tears on the back and left side of the torso and one longitudinal blister on the front.Multiple attempts were made to contact the prescribing physician; however, no reply was received.

• Brand Name: OPTUNE PAX
• Common Device Name: OPTUNE PAX
• Manufacturer (Section D): NOVOCURE GMBH
• Manufacturer Contact: sharon perez ; 180 hanover street; portsmouth, NH ; 2077527602
• MDR Report Key: 25361632
• Report Number: 3010457505-2026-00750
• Device Sequence Number: 10613241
• Product Code: SHC
• UDI-Device Identifier: 07290107987509
• UDI-Public: (01)07290107987509(11)260203
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P250034
• 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
• Report Date (Section B): 06/02/2026

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2019
• 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: 78 YR
• Patient Sex: Female