MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-08-02 for OPTUNE TFH-9100 N/A manufactured by Novocure Ltd.
[81626332]
Novocure medical opinion is that a contribution of the array placement to the event cannot be ruled out. Additional contributing factors for wound dehiscence in this patient include: intermittent scalp psoriasis, concomitant bevacizumab (vegf inhibitor which carries a black box warning for wound healing complications. Source bevacizumab prescribing information), concomitant dexamethasone (impaired wound healing is listed as a side effect. Source: dexamethasone prescribing information), prior radiation, age, 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.
Patient Sequence No: 1, Text Type: N, H10
[81626333]
A (b)(6) female with newly diagnosed glioblastoma began optune therapy plus bevacizumab on (b)(6) 2017. On (b)(6) 2017, spouse reported patient had been hospitalized for a week due to a wound complication at her surgical site. Per hospital summary, patient was seen by the prescriber on (b)(6) 2017, at which time a 2-3 mm ulcer was noted with persistent minimal purulent drainage and exposed craniotomy hardware (date of original resection (b)(6) 2016). Patient had not experienced any fever, fatigue or headache. Patient was sent to the emergency room and admitted for wound revision and removal of eroding hardware. Optune and bevacizumab treatment were discontinued upon admission. Mri taken prior to the procedure on (b)(6) 2017 did not show any signs of underlying infection. Patient was treated with prophylactic topical and oral antibiotics pre- and post-surgery. Patient resumed optune therapy on (b)(6) 2017. In a follow up appointment with the prescriber on (b)(6) 2017, the wound was noted to be healing well and was dry and intact with no sign of infection. Per the prescribing physician, the event was related to optune, steroids and bevacizumab.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009453079-2017-00087 |
| MDR Report Key | 6760974 |
| Report Source | CONSUMER |
| Date Received | 2017-08-02 |
| Date of Report | 2017-08-02 |
| Date of Event | 2017-06-02 |
| Date Mfgr Received | 2017-07-06 |
| Device Manufacturer Date | 2016-09-29 |
| Date Added to Maude | 2017-08-02 |
| 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 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| 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 | US |
| Manufacturer Postal | 31905 |
| Manufacturer G1 | NOVOCURE LTD |
| Manufacturer Street | TOPAZ BIULDING, SHA'AR HACARMEL 4TH FLOOR |
| Manufacturer City | HAIFA 31905 |
| Manufacturer Country | US |
| 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 | 2017-08-02 |
| Model Number | TFH-9100 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 8 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 US 31905 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2017-08-02 |