MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE GIO

Model Number TFH9100

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

Patient Problem Laceration(s) (1946)

Event Date 01/13/2024

Event Type  Injury  

Manufacturer Narrative

Novocure´s medical opinion is that the contribution of the transducer arrays to the skin laceration cannot be ruled out.The fall and exacerbation of chronic left shoulder subluxation were unrelated to device use.Skin laceration is an expected event with optune gio device use (ef-11 0% and 1% ef-14 optune arm).

Event Description

A 49-year-old female with recurrent glioblastoma (gbm) started optune gio therapy (b)(6) 2023.On january 13, 2024, novocure was informed by the patient that she fell forward while using the bathroom, hitting the head on a doorframe.Patient was subsequently admitted to the emergency department.The patient denied loss of consciousness, headache and blurred vision.The fall resulted in a 3 cm abrasion with 0.25 cm skin laceration.The patient was wearing optune gio device during the fall.Reportedly, one of the electrodes broke and contributed to the skin laceration.The skin laceration was closed with medical glue and patient discharged to home in stable condition the same day.Additionally, patient endorsed exacerbation of chronic left shoulder pain, following the fall.The prescribing physician was contacted, but did not provide a causality assessment.

• 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: 18666736
• MDR Text Key: 334838969
• Report Number: 3010457505-2024-00258
• 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: 02/08/2024

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/13/2024
• Initial Date FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/22/2016
• 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: ABEMACICLIB; BACLOFEN; BEVACIZUMAB; DEXAMETHASONE; L-THEANINE; LACOSAMIDE; LISINOPRIL; MELATONIN; MIRABEGRON; ONDANSETRONE; TEMOZOLOMIDE
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female