MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Date 12/10/2022

Event Type  Injury  

Manufacturer Narrative

Novocure's opinion is that a contribution of the array placement to the wound infection cannot be ruled out.Wound infection 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 (<1% and <1% in optune/tmz and tmz arms respectively).

Event Description

On december 12, 2022, novocure received an adverse event report that an unknown male patient was hospitalized on (b)(6) 2022, due to a continuous fever and swelling at the surgical resection site.Optune therapy was temporarily discontinued during the hospital stay.The patient was discharged on (b)(6) 2022, and planned to resume therapy after a one week course of unspecified antibiotics.No causality assessment from the physician was available.

• Brand Name: OPTUNE
• Type of Device: 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: 16132609
• MDR Text Key: 307029475
• Report Number: 3010457505-2023-00224
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• PMA/PMN Number: P100034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/10/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: TFH9100
• Device Catalogue Number: TFH9100AB
• Device Lot Number: N/A
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: NOT PROVIDED
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male