MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-07-08 for OPTUNE TFH 91000 N/A manufactured by Novocure, Ltd..
| Report Number | 3009453079-2019-00117 |
| MDR Report Key | 8767318 |
| Report Source | CONSUMER |
| Date Received | 2019-07-08 |
| Date of Report | 2019-07-08 |
| Date of Event | 2019-05-17 |
| Date Facility Aware | 2019-06-10 |
| Date Mfgr Received | 2019-06-10 |
| Date Added to Maude | 2019-07-08 |
| 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. SHARON PEREZ |
| Manufacturer Street | 195 COMMERCE WAY |
| Manufacturer City | PORTSMOUTH NH 03801 |
| Manufacturer Country | US |
| Manufacturer Postal | 03801 |
| Manufacturer G1 | NOVOCURE, LTD. |
| Manufacturer Street | 195 COMMERCE WAY |
| Manufacturer City | PORTSMOUTH NH 03801 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03801 |
| 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 | 2019-07-08 |
| Model Number | TFH 91000 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOVOCURE, LTD. |
| Manufacturer Address | 195 COMMERCE WAY PORTSMOUTH NH 03801 US 03801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-07-08 |