MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE GIO

Model Number TFH9100

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

Patient Problem Wound Dehiscence (1154)

Event Date 01/16/2024

Event Type  Injury  

Event Description

A 67-year-old female with newly diagnosed glioblastoma (gbm) started optune gio therapy on (b)(6) 2023, discontinued on (b)(6) 2023, and resumed on (b)(6) 2023.On (b)(6)2024, novocure was informed that when the patient removed the transducer arrays the previous day, a wound on the surgical resection site was discovered.The patient denied pain or bleeding.Reportedly, the patient experienced an itchy scalp and scratched the affected area.During the visit on (b)(6) 2024, a 2 cm wound was noted at the surgical resection site on the front right temporal region.The patient was examined by a physician and the wound dehiscence was disinfected and closed with staples.It was noted that the patient's entire scalp had erythema, dryness, and partial epidermal peeling.No causality assessment was available from the prescribing physician.

Manufacturer Narrative

Novocure opinion is that the contribution of the array placement to the reported wound dehiscence cannot be ruled out.Wound dehiscence is an expected event with optune gio device use (ef-11 0% and <1% ef-14 optune arm).Additional note: manufacturing date of (b)(6) is 2019-oct-27.

• Brand Name: OPTUNE GIO
• Type of Device: OPTUNE GIO
• 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: 18710132
• MDR Text Key: 335409945
• Report Number: 3010457505-2024-00259
• 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: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: TFH9100
• Device Catalogue Number: TFH9100JP
• Device Lot Number: N/A
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/25/2019
• 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 PROVIDED.
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female