MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-09 for OPTUNE TUMOR TREATING FIELD manufactured by Novocure Ltd..
[123492364]
Pt involved in clinical trial (this event was reported also by study coordinators to the appropriate regulatory authority) with a parp inhibitor and an alkylating chemotherapy. She was also using optune device (tumor treating field). Her liver enzymes have been gradually increasing over the last 2-3 weeks, but the values spikes yesterday. This lead to her hospitalization. It was not likely to be related to device, as she had been wearing the device significantly longer than taking the study drug and chemotherapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080431 |
| MDR Report Key | 7951753 |
| Date Received | 2018-10-09 |
| Date of Report | 2018-10-04 |
| Date of Event | 2018-10-03 |
| Date Added to Maude | 2018-10-10 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OPTUNE TUMOR TREATING FIELD |
| Generic Name | STIMULATOR, LOW ELECTRIC FIELD, TUMOR TREATMENT |
| Product Code | NZK |
| Date Received | 2018-10-09 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOVOCURE LTD. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-10-09 |