MAUDE Adverse Event Report: NOVOCURE LTD. OPTUNE; OPTUNE, PRODUCT CODE: NZK

Model Number TFH-9000

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

Patient Problem Abscess (1690)

Event Date 09/21/2015

Event Type  Injury  

Manufacturer Narrative

Novocure medical assessment is that optune did not contribute to the abscess.The skin in the area of the abscess was intact and the location was not under the array disks.Other contributing factors for abscess/infection in this patient include: chronic steroid therapy, diabetes, underlying cancer disease, prior radiation, chemotherapy and concomitant bevacizumab (vegf inhibitor which carries a black box warning for wound healing complications.Source: bevacizumab prescribing information).There were no reports of abscesses in the (b)(6) trial.There have been 2 reports of abscess in the commercial program to date; neither event was related to optune.

Event Description

Patient with recurrent glioblastoma began optune therapy on (b)(6) 2015.On (b)(6) 2015, during a routine office visit, the prescribing physician noted a small, non-open, tender area on the back of the patient's scalp in the area where the plastic piece of the array wire touched the scalp.Optune was discontinued.The following day, the soreness escalated to serious pain and the area continued to grow.On (b)(6) 2015, patient presented to the emergency room and was admitted to have the abscess drained.Following several attempts of contact with prescriber, no additional information on the hospitalization was provided.At the time of the report, the patient had not restarted optune.Spouse reported that the prescriber had attributed the event to optune, but this was not confirmed by the prescriber.

• Brand Name: OPTUNE
• Type of Device: OPTUNE, PRODUCT CODE: NZK
• Manufacturer (Section D): NOVOCURE LTD.; topaz building, sha'ar; hacarmel 4th floor; haifa, 31905 ; IS 31905
• Manufacturer (Section G): NOVOCURE LTD.; topaz building, sha'ar; hacarmel 4th floor; haifa, is 31905 ; IS 31905
• Manufacturer Contact: eilon kirson ; topaz building, sha'ar; hacarmel 4th floor; haifa, is 31905 ; IS 31905 ; 48501204
• MDR Report Key: 5160135
• MDR Text Key: 28673353
• Report Number: 3009453079-2015-00060
• Device Sequence Number: 1
• Product Code: NZK
• UDI-Device Identifier: 07290107980401
• UDI-Public: 07290107980401
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Report Date: 09/22/2015

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-9000
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Device Age: 7 MO
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2015
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 49 YR
• Patient Weight: 88