MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number	TFH9100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Post Operative Wound Infection (2446)
Date of Event	05/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure medical opinion is that a contribution of the array placement to the event cannot be ruled out.Patient was noted to have recurrent superficial scalp infections during treatment with optune.Contributing factors for wound dehiscence and wound infection in this patient also include prior radiation, chemotherapy, and prior surgery affecting skin integrity.Wound infection is an expected event with device use and was reported as an adverse event in the ef-14 trial of optune together with temozolomide (tmz) compared to tmz alone in patients with newly diagnosed gbm in both arms of the trial (<1% and <1% in optune/tmz and tmz arms respectively).Wound dehiscence was reported in the optune/tmz arm of the trial (<1%) only.
Event or Problem Description
A (b)(6) year old male patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2017.Per clinic notes, on (b)(6) 2019, patient was noted to have purulent drainage from the craniotomy wound (last resection (b)(6) 2016).Wound culture was (b)(6) for (b)(6).Medical history was noted to be significant for recurrent superficial scalp infections.Patient was started on antibiotics and a bone scan was planned to assess for osteomyelitis (no further information provided).Surgery was planned for bone revision and skin graft.Optune was discontinued.On (b)(6) 2019, the patient reported to novocure that he had undergone wound revision surgery 4 weeks prior (on approximately (b)(6) 2019).On (b)(6) 2019, patient reported that the sutures were removed on (b)(6) 2019.The patient noted that there was still some drainage and bleeding from the wound and he was experiencing discomfort and pain associated with the scar.The patient stated that sores from optune had adversely affected his scalp.Patient had been instructed to allow additional time for the surgical wound to fully heal before resuming optune therapy.Per prescribing physician, the event was unrelated to optune therapy.
Additional Manufacturer Narrative
On august 23, 2022, novocure discovered that the initial submitted medical device report had a typo in the model number for the optune device in section d4-suspect medical device model number.Corrected model number is tfh9100.In addition, the manufacturer date in section h4 was missing.The correct manufacturer date is june 27, 2016.

• Brand Name: OPTUNE
• Common Device Name: OPTUNE
• Manufacturer (Section D): NOVOCURE GMBH; business village d4; park 6/platz 10; root d4, NH 6039 ; SZ 6039
• Manufacturer (Section G): NOVOCURE GMBH; business village d4; park 6/platz 10; root d4, NH 6039 ; SZ 6039
• Manufacturer Contact: sharon perez ; 195 commerce way; portsmouth, NH 03801 ; 2077527602
• MDR Report Key: 8767318
• Report Number: 3009453079-2019-00117
• Device Sequence Number: 11238998
• Product Code: NZK
• UDI-Device Identifier: 07290107980401
• UDI-Public: 07290107980401
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: TFH9100
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/10/2019
• Device Age: 3 YR
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 07/08/2019
• Supplement Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALPRAZOLAM; BOSWILLIC ACID; EPIGALLOCATECHIN GALLATE; GENISTEIN; GRAVIOLA; LEVETIRACETAM; MEBENDAZOLE; METFORMIN; ONDANSETRON; PROCHLORPERAZINE; ROSUVASTATIN; TRETINOIN; ZINC ACETATE; ALPRAZOLAM; BOSWILLIC ACID; EPIGALLOCATECHIN GALLATE; GENISTEIN; GRAVIOLA; LEVETIRACETAM; MEBENDAZOLE; METFORMIN; ONDANSETRON; PROCHLORPERAZINE; ROSUVASTATIN; TRETINOIN; ZINC ACETATE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 92 KG