MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-07-19 for OPTUNE TFH-9100 N/A manufactured by Novocure, Ltd..
[114422869]
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 dexamethasone use (impaired wound healing and increased risk of infection are listed as side effects. Source: dexamethasone prescribing information), prior radiation, underlying cancer disease, and prior surgery affecting skin integrity. There were no reports of wound dehiscence in the (b)(6) trial. In the commercial program, wound dehiscence has been reported by <1% of patients to date.
Patient Sequence No: 1, Text Type: N, H10
[114422910]
A (b)(6) female patient with recurrent glioblastoma began optune therapy on (b)(6) 2017. On (b)(6) 2018, patient was hospitalized due to wound dehiscence with the bone cement visible under the resection scar (most recent tumor resection: (b)(6) 2018). Wound revision and removal of bone cement was performed on (b)(6) 2018. Post-operative wound healing was without complications and patient was discharged on (b)(6) 2018, with suture still in place. Treating physician was contacted for additional information; he provided the hospital summary but did not provide a causality assessment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009453079-2018-00106 |
| MDR Report Key | 7702348 |
| Report Source | CONSUMER |
| Date Received | 2018-07-19 |
| Date of Report | 2018-07-19 |
| Date of Event | 2018-05-23 |
| Date Mfgr Received | 2018-06-22 |
| Device Manufacturer Date | 2017-09-10 |
| Date Added to Maude | 2018-07-19 |
| 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 | 2018-07-19 |
| 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 IS 31905 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-07-19 |