OCEAN CHEST DRAIN Adverse Event — Injury (MDR 3011175548-2020-00584)
OCEAN CHEST DRAIN Adverse Event — Injury (MDR 3011175548-2020-00584) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: OCEAN CHEST DRAIN; Generic name: APPARATUS, AUTOTRANSFUSION; Manufacturer: ATRIUM MEDICAL CORPORATION.
| Device | OCEAN CHEST DRAIN |
|---|---|
| Generic name | APPARATUS, AUTOTRANSFUSION |
| Manufacturer | ATRIUM MEDICAL CORPORATION |
| Report number | 3011175548-2020-00584 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | WE ARE UNABLE TO FULLY INVESTIGATE THIS REPORT AS NO PRODUCT NUMBER, LOT NUMBER OR SAMPLE WAS PROVIDED. IT IS NOT KNOWN WHAT RELATIONSHIP THE OCEAN CHEST DRAIN HAS TO THE REPORTED ADVERSE EVENTS. THE ARTICLE CONCLUDED THAT DIGITAL DRAINAGE SYSTEMS CAN BE SAFELY APPLIED IN CARDIAC SURGERY PATIENTS. THE USE OF THE DIGITAL MANAGEMENT SYSTEM LED TO A DECREASED INCIDENCE OF DRAINAGE ASSOCIATED COMPLICA |
| Source | openFDA MAUDE (device adverse events) |
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