MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 08/24/2021

Event Type  Injury  

Manufacturer Narrative

Novocure medical opinion is that a contribution of the array placement to the event cannot be ruled out.Contributing factors for medical device site reaction in this patient include: radiation, chemotherapy and prior surgery affecting skin integrity.Medical device site reaction is an expected event with device use and was reported as an adverse event in the ef-11 trial in the optune arm of the trial (16%).

Event Description

A (b)(6) male patient with anaplastic astrocytoma began optune therapy on (b)(6) 2021.On (b)(6) 2021, novocure received a report that on an unspecified date the patient was hospitalized due to irritation on the scalp.Optune therapy was temporarily discontinued.Upon resuming optune, the prescribing physician suggested a new skin regimen and to allow the scalp to "breath" for one hour before applying the transducer arrays.Prescribing physician was contacted several times however, a causality assessment was not provided.

• 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: 12494890
• MDR Text Key: 272134799
• Report Number: 3009453079-2021-00186
• Device Sequence Number: 1
• Product Code: NZK
• 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
• Type of Report: Initial
• Report Date: 09/20/2021

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: 08/24/2021
• Initial Date FDA Received: 09/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2016
• 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: DEXAMETHASONE; ENOXAPARIN; IPRATROPIUM-ALBUTEROL; LEVETIRACETAM; METOPROLOL SUCCINATE; METOPROLOL TARTRATE; MICONAZOLE CREAM; NEOMYCIN-BACITRACIN-POLYMYXIN OINTMENT; NYSTATIN ORAL; OMEPRAZOLE; ONDANSETRON; OXYMORPHONE; PHENYTOIN; SULFAMETHOXAZOLE-TRIMETHOPRIM; TEMOZOLOMIDE
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR
• Patient Weight: 84