OPTUNE Adverse Event — Injury (MDR 3009453079-2020-00140)
OPTUNE Adverse Event — Injury (MDR 3009453079-2020-00140) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: OPTUNE; Generic name: OPTUNE; Manufacturer: NOVOCURE, LTD..
| Device | OPTUNE |
|---|---|
| Generic name | OPTUNE |
| Manufacturer | NOVOCURE, LTD. |
| Report number | 3009453079-2020-00140 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-27 |
| Report source | CONSUMER |
| Narrative | NOVOCURE'S OPINION IS THAT A CONTRIBUTION OF THE ARRAY PLACEMENT TO THE ULCERATION CANNOT BE RULED OUT. CONTRIBUTING FACTORS FOR SKIN ULCER IN THIS PATIENT INCLUDE: PRIOR RADIATION, UNDERLYING CANCER DISEASE AND PRIOR SURGERY AFFECTING SKIN INTEGRITY. MEDICAL DEVICE SITE ULCER IS AN EXPECTED EVENT WITH DEVICE USE AND WAS REPORTED AS AN ADVERSE EVENT IN THE EF-14 TRIAL OF OPTUNE TOGETHER WITH TEMOZ |
| Source | openFDA MAUDE (device adverse events) |
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