MAUDE Adverse Event Report: NOVOCURE, LTD. OPTUNE

Model Number TFH-9100

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 11/26/2018

Event Type  Injury  

Manufacturer Narrative

Novocure agrees with the prescribing physician that a contribution of the array placement to the event cannot be ruled out.Contributing factors for wound infection in this patient include prior radiation, chemotherapy, underlying cancer disease, and prior surgery affecting skin integrity.Wound infection was not reported as adverse event in the (b)(6) trial.(b)(4).

Event Description

A (b)(6) female patient with recurrent glioblastoma began optune therapy on (b)(6) 2018.On (b)(6) 2018, the husband reported that patient was hospitalized the prior week due to an infection of the scalp and the resection scar (most recent resection (b)(6) 2018) requiring surgical intervention.The prescribing physician suspected that the wound infection was caused by prior resection surgery, radiation, and optune therapy.

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• Manufacturer (Section D): NOVOCURE, LTD.; topaz building, sha'ar; hacarmel 4th floor; haifa, is 31905 ; IS 31905
• Manufacturer (Section G): NOVOCURE, LTD.; topaz building, sha'ar; hacarmel 4th floor; haifa, 31905 ; IS 31905
• Manufacturer Contact: eilon kirson ; topaz building, sha'ar; hacarmel 4th floor; haifa 31905 ; 9724850120
• MDR Report Key: 8155042
• MDR Text Key: 130048998
• Report Number: 3009453079-2018-00111
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/12/2018

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: TFH-9100
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Device Age: 2 YR
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2016
• 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: LEVETIRACETAM; VALPROIC ACID
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 41 YR