MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-04-17 for OPTUNE TFH-91000 N/A manufactured by Novocure Ltd.
[105720516]
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: dexamethasone use (impaired wound healing and increased risk of infection are listed as side effects. Source: dexamethasone prescribing information), 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 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).
Patient Sequence No: 1, Text Type: N, H10
[105720517]
A (b)(6) female patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2018. On march 19, 2018 the patient reported that during an array change on (b)(6) 2018, a yellow discharge with a foul smell was noted. Optune therapy was temporarily discontinued. On (b)(6) 2018, novocure was informed by the prescribing physician that the patient was being treated for wound dehiscence with a povidone iodine sugar paste ointment. On (b)(6) 2018, the prescribing physician reported the wound dehiscence had worsened and the cranial bone beneath the wound was scheduled to be removed on (b)(6) 2018, due to wound infection. The prescriber stated that the bone would not be replaced and therefore there was no plan to restart optune therapy after the surgery. Per the prescribing physician, the patient's skin was fragile and the physical force from removing the transducer arrays caused the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009453079-2018-00096 |
| MDR Report Key | 7437805 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-04-17 |
| Date of Report | 2018-04-17 |
| Date of Event | 2018-03-16 |
| Date Mfgr Received | 2018-04-10 |
| Device Manufacturer Date | 2017-11-07 |
| Date Added to Maude | 2018-04-17 |
| 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, IL 31905 |
| Manufacturer Country | IS |
| Manufacturer Postal | 31905 |
| Manufacturer G1 | NOVOCURE LTD |
| Manufacturer Street | TOPAZ BUILDING, SHA'AR HACARMEL 4TH FLOOR |
| Manufacturer City | HAIFA, IL 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 | 2018-04-17 |
| Model Number | TFH-91000 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 5 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, IL 31905 IS 31905 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-04-17 |