REVIVE SE 4.5MM OUS Adverse Event — Injury (MDR 3008114965-2020-00141)
REVIVE SE 4.5MM OUS Adverse Event — Injury (MDR 3008114965-2020-00141) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: REVIVE SE 4.5MM OUS; Generic name: EMBOLECTOMY CATHETER; Manufacturer: MEDOS INTERNATIONAL SARL.
| Device | REVIVE SE 4.5MM OUS |
|---|---|
| Generic name | EMBOLECTOMY CATHETER |
| Manufacturer | MEDOS INTERNATIONAL SARL |
| Report number | 3008114965-2020-00141 |
| Event type | Injury |
| Date received | 2020-04-27 |
| Report source | FOREIGN, LITERATURE |
| Narrative | PRODUCT COMPLAINT # (B)(4). SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE |
| Source | openFDA MAUDE (device adverse events) |
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