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 2019-01-03 for OPTUNE TFH-9100 N/A manufactured by Novocure, Ltd..
[131982864]
Novocure medical opinion is that a contribution of the array placement to the event cannot be ruled out. Contributing factors for wound dehiscence in this patient include carmustine implant (carries a warning for impaired neurosurgical wound healing including wound dehiscence, delayed wound healing, and subdural, subgaleal, or wound effusions. Source: carmustine prescribing information), dexamethasone use (impaired wound healing and increased risk of infection are listed as side effects. Source: dexamethasone prescribing information), prior radiation, chemotherapy, prior surgery, and prior wound complication affecting skin integrity. Wound dehiscence was reported as an adverse event in the (b)(6) 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
[131982865]
A (b)(6) year old female patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2018, as part of (b)(6). On (b)(6) 2018, patient temporarily discontinued optune therapy due to a planned tumor recurrence resection on (b)(6) 2018, with carmustine implantation. On (b)(6) 2018, patient's bone flap was removed due to wound healing complications. Patient resumed optune therapy on (b)(6) 2018. On (b)(6) 2018, patient was again hospitalized due to wound healing complications, requiring surgical wound revision, which was performed on (b)(6) 2018. Postoperative course was without complications, wound culture was negative. On (b)(6) 2018, patient was discharged home. Prescriber was contacted for further information without response.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009453079-2019-00112 |
| MDR Report Key | 8212886 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2019-01-03 |
| Date of Report | 2019-01-31 |
| Date of Event | 2018-12-01 |
| Date Mfgr Received | 2018-01-16 |
| Device Manufacturer Date | 2016-03-31 |
| Date Added to Maude | 2019-01-03 |
| 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 | US |
| Manufacturer Postal | 31905 |
| Manufacturer Phone | 9724850120 |
| 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 | 2019-01-03 |
| Model Number | TFH-9100 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 32 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, IS 31905 IS 31905 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-01-03 |