MICROAIRE CANNULA PAL-R30MLS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-13 for MICROAIRE CANNULA PAL-R30MLS manufactured by Microaire Surgical Instruments.

Event Text Entries

[114287232] While performing a liposuction procedure on a patient's inner knee, the cannula being used fractured. There was no patient injury. The broken cannula piece was removed and no additional medical intervention was necessary.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2020601-2018-00005
MDR Report Key7687452
Date Received2018-07-13
Date of Report2018-07-13
Date of Event2018-06-16
Date Mfgr Received2018-08-15
Device Manufacturer Date2017-07-26
Date Added to Maude2018-07-13
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 BLVD.
Manufacturer CityCHARLOTTESVILLE VA 22911
Manufacturer CountryUS
Manufacturer Postal22911
Manufacturer G1MICROAIRE SURGICAL INSTRUMENTS
Manufacturer Street3590 GRAND FORKS BLVD.
Manufacturer CityCHARLOTTESVILLE VA 22911
Manufacturer CountryUS
Manufacturer Postal Code22911
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameMICROAIRE CANNULA
Generic Name3.0MM MULTI-USE CANNULA
Product CodeMUU
Date Received2018-07-13
Model NumberPAL-R30MLS
Catalog NumberPAL-R30MLS
Lot Number0717311441
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMICROAIRE SURGICAL INSTRUMENTS
Manufacturer Address3590 GRAND FORKS BLVD. CHARLOTTESVILLE VA 22911 US 22911


Patients

Patient NumberTreatmentOutcomeDate
10 2018-07-13

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