MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2018-05-31 for OPTUNE TFH-9100 N/A manufactured by Novocure, Ltd..
[109631786]
Novocure medical opinion is that a contribution of the array placement to the event cannot be ruled out. Contributing factors for wound dehiscence and wound infection in this patient include concomitant bevacizumab (carries a black box warning for wound complications. Source: bevacizumab prescribing information), 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 optune together with temozolomide (tmz) compared to tmz alone in patients with newly diagnosed gbm in the optune/tmz arm of the trial (<1%) only. Wound infection was reported as in the ef-14 trial in both arms of the trial (<1%and <1% in optune/tmz and tmz arms respectively).
Patient Sequence No: 1, Text Type: N, H10
[109631787]
A (b)(6) male patient with newly diagnosed glioblastoma began optune therapy with concurrent bevacizumab on (b)(6) 2018. On (b)(6) 2018, during an array change, the spouse noticed the patient's metal plate was exposed (most recent craniotomy: (b)(6) , 2017). That same day, the patient developed an acute fever. On (b)(6) 2018, patient was admitted to the hospital for wound dehiscence and optune therapy was temporarily discontinued. On (b)(6) 2018, patient underwent a wound revision and removal of infected bone flap. On april 10, 2018, the patient was discharged to acute inpatient rehabilitation. Prescribing physician was contacted and provided additional information on the event but did not provide a causality assessment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009453079-2018-00101 |
| MDR Report Key | 7556473 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2018-05-31 |
| Date of Report | 2018-05-31 |
| Date of Event | 2018-03-29 |
| Date Mfgr Received | 2018-05-17 |
| Device Manufacturer Date | 2017-07-27 |
| Date Added to Maude | 2018-05-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. EILON KIRSON |
| Manufacturer Street | TOPAZ BUILDING, SHA'AR HACARMEL 4TH FLOOR |
| Manufacturer City | HAIFA, 31905 |
| Manufacturer Country | IS |
| Manufacturer Postal | 31905 |
| Manufacturer G1 | NOVOCURE, LTD. |
| Manufacturer Street | TOPAZ BUILDING, SHA'AR HACARMEL 4TH FLOOR |
| Manufacturer City | HAIFA, 31905 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 31905 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTUNE |
| Generic Name | OPTUNE |
| Product Code | NZK |
| Date Received | 2018-05-31 |
| Model Number | TFH-9100 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 10 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOVOCURE, LTD. |
| Manufacturer Address | TOPAZ BUILDING, SHA'AR HACARMEL 4TH FLOOR HAIFA, 31905 IS 31905 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-05-31 |