MICROAIRE CANNULA PAL-R408LL

MAUDE Adverse Event Report

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.

MAUDE Entry Details

Report Number2020601-2020-00194
MDR Report Key9802781
Report SourceDISTRIBUTOR
Date Received2020-03-06
Date of Report2020-03-06
Date of Event2020-02-04
Date Mfgr Received2020-02-05
Device Manufacturer Date2018-08-13
Date Added to Maude2020-03-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. BRIAN AMELL
Manufacturer Street3590 GRAND FORKS BOULEVARD
Manufacturer CityCHARLOTTESVILLE, VA
Manufacturer CountryUS
Manufacturer Phone9758394
Manufacturer G1MICROAIRE SURGICAL INSTRUMENTS, LLC
Manufacturer Street3590 GRAND FORKS BOULEVARD
Manufacturer CityCHARLOTTESVILLE, VA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMICROAIRE CANNULA
Generic Name4.0MM MULTI-USE CANNULA
Product CodeMUU
Date Received2020-03-06
Returned To Mfg2020-02-14
Model NumberPAL-R408LL
Catalog NumberPAL-R408LL
Lot Number0818329022
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMICROAIRE SURGICAL INSTRUMENTS, LLC
Manufacturer Address3590 GRAND FORKS BOULEVARD CHARLOTTESVILLE, VA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-06

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