MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-09-25 for OPTUNE TFH-9100 N/A manufactured by Novocure, Ltd..
[121583734]
Novocure medical opinion is that although the prescriber assessed this event as not related to optune, a contribution of array placement to the wound dehiscence cannot be ruled out. Contributing factors for wound dehiscence in this patient also include dexamethasone use (impaired wound healing and increased risk of infection are listed as side effects. Source: dexamethasone prescribing information), prior radiation, chemotherapy, and prior surgery affecting skin integrity. There were no reports of wound dehiscence in the pivotal ef- 11 recurrent gbm trial. In the commercial program, wound dehiscence has been reported by <1% of patients to date.
Patient Sequence No: 1, Text Type: N, H10
[121583735]
A (b)(6) female patient with recurrent glioblastoma began optune therapy on (b)(6) 2018. On september 03, 2018, novocure was informed by the spouse that the patient was hospitalized due to wound dehiscence at the resection scar (most recent resection (b)(6) 2018). The pictures provided by the spouse show a large area of wound dehiscence along the resection scar (according to medical record about 1. 2x7 cm) with the exposed bone visible. There were no signs of wound infection. On (b)(6) 2018, it was reported to novocure that the patient underwent surgical wound revision. The prescribing physician stated that event was not related to optune therapy; she assessed the event to be due to prior radiation and long-term dexamethasone administration. Optune therapy was temporarily discontinued since (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009453079-2018-00107 |
| MDR Report Key | 7905528 |
| Report Source | CONSUMER |
| Date Received | 2018-09-25 |
| Date of Report | 2018-09-25 |
| Date of Event | 2018-09-03 |
| Date Mfgr Received | 2018-10-26 |
| Device Manufacturer Date | 2016-11-24 |
| Date Added to Maude | 2018-09-25 |
| 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 | OPTUE |
| Product Code | NZK |
| Date Received | 2018-09-25 |
| Model Number | TFH-9100 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 21 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 | 2018-09-25 |