OPTUNE Adverse Event — Injury (MDR 3009453079-2020-00143)
OPTUNE Adverse Event — Injury (MDR 3009453079-2020-00143) 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 | 3009453079-2020-00143 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| Report source | CONSUMER |
| Narrative | NOVOCURE MEDICAL OPINION IS THAT A CONTRIBUTION OF THE ARRAY PLACEMENT TO THE EVENTS CANNOT BE RULED OUT. CONTRIBUTING FACTORS FOR WOUND DEHISCENCE AND WOUND INFECTION IN THIS PATIENT ALSO INCLUDE CONCOMITANT CARMUSTINE (CARRIES A WARNING FOR IMPAIRED NEUROSURGICAL WOUND HEALING. SOURCE: CARMUSTINE PRESCRIBING INFORMATION), CONCOMITANT DEXAMETHASONE (IMPAIRED WOUND HEALING AND INCREASED RISK OF IN |
| Source | openFDA MAUDE (device adverse events) |
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