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 |