MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-20 for MICROAIRE CANNULA PAL-R405LL manufactured by Microaire Surgical Instruments, Llc.
| Report Number | 2020601-2019-00010 |
| MDR Report Key | 9100497 |
| Date Received | 2019-09-20 |
| Date of Report | 2019-09-20 |
| Date of Event | 2019-08-21 |
| Date Mfgr Received | 2019-08-22 |
| Device Manufacturer Date | 2017-08-15 |
| Date Added to Maude | 2019-09-20 |
| 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 22902 |
| Manufacturer Country | US |
| Manufacturer Postal | 22902 |
| Manufacturer Phone | 4349758394 |
| Manufacturer G1 | MICROAIRE SURGICAL INSTRUMENTS, LLC |
| Manufacturer Street | 3590 GRAND FORKS BOULEVARD |
| Manufacturer City | CHARLOTTESVILLE VA 22902 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 22902 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MICROAIRE CANNULA |
| Generic Name | 4.0MM MULTI-USE CANNULA |
| Product Code | MUU |
| Date Received | 2019-09-20 |
| Model Number | PAL-R405LL |
| Catalog Number | PAL-R405LL |
| Lot Number | 0817312446 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROAIRE SURGICAL INSTRUMENTS, LLC |
| Manufacturer Address | 3590 GRAND FORKS BOULEVARD CHARLOTTESVILLE VA 22902 US 22902 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-20 |