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 Code	Skin Inflammation/ Irritation (4545)
Date of Event	06/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A 54-year-old female patient with pancreatic adenocarcinoma (nos) started optune pax therapy on (b)(6) 2026.On (b)(6) 2026, the patient informed novocure that she experienced ongoing skin irritation, erythema, blistering, and open lesions beneath all arrays for the past month.The patient's healthcare provider (hcp) prescribed a triamcinolone-containing topical ointment and advised application twice daily to affected areas.The patient used the prescribed ointment and rotated the arrays to avoid the affected areas.Four photographs of the abdomen, back, and bilateral flanks were provided.The photographs showed several linear erythematous lesions.Multiple open and crusted lesions were visible on the back and left flank.On (b)(6) 2026, the patient reported worsening skin irritation compared with the previous week.Five additional photographs were provided, demonstrating multiple lesions with moderate-to-severe erythema.Several areas of superficial erosion and scabbing were also observed.The patient reported visiting a physician on (b)(6) 2026, and was prescribed cephalexin 500 mg three times daily.The patient interrupted optune pax therapy for two days and resumed treatment on (b)(6) 2026.Multiple attempts were made to contact the prescribing physician; however, no reply was received.
Additional Manufacturer Narrative
Novocure's medical opinion is that the contribution of the transducer arrays to the skin inflammation/irritation requiring medical intervention cannot be ruled out.Skin reaction was reported in the pivotal ef-27 clinical trial for optune pax treatment for locally advanced pancreatic cancer (7.3% in the ttfields arm and 3.3% in the control arm).

• Brand Name: Optune Pax
• Common Device Name: Optune Pax
• Manufacturer (Section D): NOVOCURE GmbH
• Manufacturer Contact: sharon perez ; 180 hanover street; portsmouth, NH ; +1(207)752-7602
• MDR Report Key: 50004887
• Report Number: 3010457505-2026-00813
• Device Sequence Number: 10242429
• Product Code: SHC
• UDI-Device Identifier: 07290107987509
• UDI-Public: (01)07290107987509(11)260127
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 07/23/2026

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
• Initial Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2026
• 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: 54 YR
• Patient Sex: Female