MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-06 for MICROAIRE CANNULA PAL-R408LL manufactured by Microaire Surgical Instruments, Llc.
| Report Number | 2020601-2020-00194 |
| MDR Report Key | 9802781 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-02-04 |
| Date Mfgr Received | 2020-02-05 |
| Device Manufacturer Date | 2018-08-13 |
| Date Added to Maude | 2020-03-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BRIAN AMELL |
| Manufacturer Street | 3590 GRAND FORKS BOULEVARD |
| Manufacturer City | CHARLOTTESVILLE, VA |
| Manufacturer Country | US |
| Manufacturer Phone | 9758394 |
| Manufacturer G1 | MICROAIRE SURGICAL INSTRUMENTS, LLC |
| Manufacturer Street | 3590 GRAND FORKS BOULEVARD |
| Manufacturer City | CHARLOTTESVILLE, VA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROAIRE CANNULA |
| Generic Name | 4.0MM MULTI-USE CANNULA |
| Product Code | MUU |
| Date Received | 2020-03-06 |
| Returned To Mfg | 2020-02-14 |
| Model Number | PAL-R408LL |
| Catalog Number | PAL-R408LL |
| Lot Number | 0818329022 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROAIRE SURGICAL INSTRUMENTS, LLC |
| Manufacturer Address | 3590 GRAND FORKS BOULEVARD CHARLOTTESVILLE, VA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-06 |