MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-12-12 for OPTUNE TFH-9100 N/A manufactured by Novocure, Ltd..
[130048998]
Novocure agrees with the prescribing physician that a contribution of the array placement to the event cannot be ruled out. Contributing factors for wound infection in this patient include prior radiation, chemotherapy, underlying cancer disease, and prior surgery affecting skin integrity. Wound infection was not reported as adverse event in the (b)(6) trial. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[130048999]
A (b)(6) female patient with recurrent glioblastoma began optune therapy on (b)(6) 2018. On (b)(6) 2018, the husband reported that patient was hospitalized the prior week due to an infection of the scalp and the resection scar (most recent resection (b)(6) 2018) requiring surgical intervention. The prescribing physician suspected that the wound infection was caused by prior resection surgery, radiation, and optune therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009453079-2018-00111 |
| MDR Report Key | 8155042 |
| Report Source | CONSUMER |
| Date Received | 2018-12-12 |
| Date of Report | 2018-12-12 |
| Date of Event | 2018-11-26 |
| Date Mfgr Received | 2018-12-03 |
| Device Manufacturer Date | 2016-05-18 |
| Date Added to Maude | 2018-12-12 |
| 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 | 2018-12-12 |
| Model Number | TFH-9100 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 2 YR |
| 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 | 2018-12-12 |