SOLERO MICROWAVE TISSUE ABLATION APPLICATOR (14CM) Adverse Event — Injury (MDR 1317056-2020-00074)
SOLERO MICROWAVE TISSUE ABLATION APPLICATOR (14CM) Adverse Event — Injury (MDR 1317056-2020-00074) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SOLERO MICROWAVE TISSUE ABLATION APPLICATOR (14CM); Generic name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES; Manufacturer: ANGIODY
| Device | SOLERO MICROWAVE TISSUE ABLATION APPLICATOR (14CM) |
|---|---|
| Generic name | SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES |
| Manufacturer | ANGIODYNAMICS |
| Report number | 1317056-2020-00074 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | AS THE REPORTED DEFECTIVE DEVICE WAS NOT RETURNED, ANGIODYNAMICS IS UNABLE TO PERFORM A DEVICE EVALUATION. THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION CANNOT BE CONFIRMED, NO SAMPLE WAS RETURNED. WITHOUT RECEIVING PRODUCT FOR EVALUATION, WE ARE UNABLE TO DEFINITIVELY DETERMINE A ROOT CAUSE FOR THIS INCIDENT. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE REPORTED PACKAGING AND COMP |
| Source | openFDA MAUDE (device adverse events) |
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