MICROAIRE CANNULA PAL-R405LL

MAUDE Adverse Event Report

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.

MAUDE Entry Details

Report Number2020601-2019-00010
MDR Report Key9100497
Date Received2019-09-20
Date of Report2019-09-20
Date of Event2019-08-21
Date Mfgr Received2019-08-22
Device Manufacturer Date2017-08-15
Date Added to Maude2019-09-20
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 22902
Manufacturer CountryUS
Manufacturer Postal22902
Manufacturer Phone4349758394
Manufacturer G1MICROAIRE SURGICAL INSTRUMENTS, LLC
Manufacturer Street3590 GRAND FORKS BOULEVARD
Manufacturer CityCHARLOTTESVILLE VA 22902
Manufacturer CountryUS
Manufacturer Postal Code22902
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameMICROAIRE CANNULA
Generic Name4.0MM MULTI-USE CANNULA
Product CodeMUU
Date Received2019-09-20
Model NumberPAL-R405LL
Catalog NumberPAL-R405LL
Lot Number0817312446
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMICROAIRE SURGICAL INSTRUMENTS, LLC
Manufacturer Address3590 GRAND FORKS BOULEVARD CHARLOTTESVILLE VA 22902 US 22902


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-20

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