MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

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

Patient Problem Wound Dehiscence (1154)

Event Date 08/09/2022

Event Type  Injury  

Manufacturer Narrative

Novocure opinion is that the contribution of the array placement to wound dehiscence cannot be ruled out.Contributing factors for wound dehiscence in this patient include: prior dexamethasone use (impaired wound healing and increased risk of infection are listed as side effects.Source: dexamethasone prescribing information), prior radiation, underlying cancer disease, and prior surgery affecting skin integrity.Wound dehiscence was reported as an adverse event in the ef-14 trial of (b)(4) together with temozolomide (tmz) compared to tmz alone in patients with newly diagnosed gbm in the optune/tmz arm of the trial (<1%) only.

Event Description

A 61-year-old female patient with newly diagnosed glioblastoma (gbm) started optune therapy on (b)(6) 2022.Patient underwent resection surgery of gbm recurrence scheduled on (b)(6) 2022.(b)(4) therapy was temporarily discontinued.(b)(4) therapy was resumed on (b)(6) 2022, arrays were placed to avoid the surgical scar as much as possible.On (b)(6) 2022, the patient informed novocure that she was scheduled for surgery on (b)(6) 2022, to close a non-healing wound.Optune therapy was temporarily discontinued starting (b)(6) 2022.Prescribing physician was contacted for further details, without response.

• 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: 15373942
• MDR Text Key: 299452037
• Report Number: 3010457505-2022-00217
• Device Sequence Number: 1
• Product Code: NZK
• UDI-Device Identifier: 07290107982221
• UDI-Public: 07290107982221
• 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: 09/07/2022

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: TFH9100US
• Device Lot Number: N/A
• Initial Date Manufacturer Received: 08/12/2022
• Initial Date FDA Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/07/2016
• 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: ACYCLOVIR; DEXAMETHASONE; LANSOPRAZOLE; METHYLPHENIDATE; ONDANSETRON; OXYCODONE; PROCHLORPERAZINE MALEATE; RIZATRIPTAN; SULFAMETHAOXAZOLE-TRIMETHOPRIM; TEMOZOLOMIDE; TOPIRAMATE; ZOLPIDEM
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 78 KG