MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

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

Patient Problems Skin Erosion (2075); Post Traumatic Wound Infection (2447)

Event Date 08/01/2021

Event Type  Injury  

Manufacturer Narrative

Novocure's medical opinion is that a contribution of the arrays to wound infection and skin erosion cannot be ruled out.Contributing factors for skin erosion and wound infection in this patient include: prior radiation, underlying cancer disease and prior surgery affecting skin integrity.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).Skin erosion 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 the tmz arm of the trial (<1%) only.

Event Description

A (b)(6) female patient with newly diagnosed glioblastoma (gbm) began optune therapy on (b)(6) 2021.On august 04, 2021, the patient reported that on (b)(6) 2021, she experienced redness, swelling and fever at the craniotomy surgical resection site.The patient was examined at the hospital, administered antibiotic drip infusion for a suspected wound infection on the scalp and discharged home.On (b)(6) 2021, the prescribing physician admitted the patient to the hospital for administration of unspecified antibiotics.Optune therapy was temporarily discontinued.The prescriber assessed the cause of the event as progressive skin erosion resulting in a wound infection after applying the transducer arrays.

• 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: 12525815
• MDR Text Key: 273107337
• Report Number: 3009453079-2021-00183
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/24/2021

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: N/A
• Device Lot Number: N/A
• Initial Date Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 09/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: NOT AVAILABLE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR