MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-03-16 for OPTUNE TFH-9100 N/A manufactured by Novocure Ltd.
[102626967]
Novocure medical opinion is that a contribution of the array placement to the event cannot be ruled out. Contributing factors for wound infection and wound dehiscence in this patient include concomitant bevacizumab (vegf inhibitor which carries a black box warning for wound healing complications. Source: bevacizumab prescribing information), concomitant dexamethasone (impaired wound healing and increased risk of infection are listed as side effects. Source: dexamethasone prescribing information. ), prior radiation, chemotherapy, and prior surgeries affecting skin integrity. Wound infection and wound dehiscence were not reported as adverse events in (b)(6) trial. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[102626968]
A (b)(6) male patient with recurrent anaplastic oligodendroglioma began optune therapy with concurrent bevacizumab on (b)(6) 2018. On (b)(6) 2018, the patient was admitted to the hospital from the emergency department with purulent drainage from the left frontal biopsy incision site (biopsy performed on (b)(6) 2017). Optune therapy was temporarily discontinued. Patient was started on oral antibiotic (cephalexin). Head mri was negative for abscess. On (b)(6) 2018, wound drainage stopped and patient was discharged home with instructions to continue with antibiotic for two weeks and follow-up for possible wound revision. Aspirin and bevacizumab were put on hold. On (b)(6) 2018, patient was admitted to neurosurgery for continued wound drainage and wound dehiscence. On (b)(6) 2018, patient underwent wound washout and removal of cranial titanium mesh hardware. Patient was started on empirical antibiotics (vancomycin and cefepime) pending preliminary culture results. Final cultures grew coagulase negative staphylococcus. Cefepime was discontinued and patient was started on linezolid. On (b)(6) 2018, the patient was discharged home in stable condition. Per prescribing physician, cause of the event was (b)(6) infection and the event was not related to optune therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009453079-2018-00094 |
| MDR Report Key | 7345347 |
| Report Source | CONSUMER |
| Date Received | 2018-03-16 |
| Date of Report | 2018-03-16 |
| Date of Event | 2018-02-10 |
| Date Mfgr Received | 2018-02-22 |
| Device Manufacturer Date | 2016-11-30 |
| Date Added to Maude | 2018-03-16 |
| 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 | 2018-03-16 |
| Model Number | TFH-9100 |
| Catalog Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 15 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 | 2018-03-16 |