CONSTELLATION ULTRAVIT PROBE PROCEDURE PAK Adverse Event — Injury (MDR 1644019-2020-00219)
CONSTELLATION ULTRAVIT PROBE PROCEDURE PAK Adverse Event — Injury (MDR 1644019-2020-00219) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: CONSTELLATION ULTRAVIT PROBE PROCEDURE PAK; Generic name: GENERAL SURGERY TRAY (KIT); Manufacturer: ALCON RESEARCH, LLC - HOUSTON.
| Device | CONSTELLATION ULTRAVIT PROBE PROCEDURE PAK |
|---|---|
| Generic name | GENERAL SURGERY TRAY (KIT) |
| Manufacturer | ALCON RESEARCH, LLC - HOUSTON |
| Report number | 1644019-2020-00219 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-27 |
| Report source | FOREIGN, HEALTH PROFESSIONAL |
| Narrative | INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). |
| Source | openFDA MAUDE (device adverse events) |
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