MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-04-06 for OPTUNE TFH-91000 N/A manufactured by Novocure Ltd.
[104566452]
Novocure medical opinion is that a contribution of array placement to this event cannot be ruled out. Contributing factors for wound infection in this patient include concomitant carmustine (carries warnings for intracranial infection and abnormal wound healing; source: carmustine prescribing information), 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).
Patient Sequence No: 1, Text Type: N, H10
[104566453]
Patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2017. On (b)(6) 2018, the patient's spouse reported that the patient had been hospitalized due to a bone flap infection (date of most recent craniotomy: (b)(6) 2017). The bone flap was removed and patient was started on a 6 week course of iv antibiotics with a plan to replace bone defect at a later date. The prescribing physician was contacted for additional information with no response. Per medical record review, the patient had also experienced a bone flap infection prior to starting optune therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009453079-2018-00095 |
| MDR Report Key | 7402880 |
| Report Source | CONSUMER |
| Date Received | 2018-04-06 |
| Date of Report | 2018-04-06 |
| Date of Event | 2018-03-12 |
| Date Mfgr Received | 2018-03-12 |
| Device Manufacturer Date | 2016-10-07 |
| Date Added to Maude | 2018-04-06 |
| 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 | 2018-04-06 |
| Model Number | TFH-91000 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 17 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 | 2018-04-06 |