MICROAIRE 6130 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2004-08-12 for MICROAIRE 6130 * manufactured by Microaire Surgical Instruments.

Event Text Entries

[361835] Microaire received a report that a pt received an unspecified burn in the mouth area, during a procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2020601-2004-00003
MDR Report Key539115
Report Source05,06
Date Received2004-08-12
Date of Report2004-08-11
Date of Event2004-07-12
Date Mfgr Received2004-07-20
Device Manufacturer Date2002-09-01
Date Added to Maude2004-08-17
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 Location0
Manufacturer ContactTODD MOORE
Manufacturer Street1641 EDLICH DR.
Manufacturer CityCHARLOTTESVILLE VA 22911
Manufacturer CountryUS
Manufacturer Postal22911
Manufacturer Phone4349758336
Manufacturer G1MICROAIRE SURGICAL INSTRUMENTS
Manufacturer Street1641 EDLICH DR.
Manufacturer CityCHARLOTTESVILLE VA 22911
Manufacturer CountryUS
Manufacturer Postal Code22911
Single Use3
Remedial ActionRP
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameMICROAIRE
Generic NameHIGH SPEED DRILL
Product CodeDWI
Date Received2004-08-12
Returned To Mfg2004-07-22
Model Number6130
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key528410
ManufacturerMICROAIRE SURGICAL INSTRUMENTS
Manufacturer Address1641 EDLICH DR. CHARLOTTESVILLE VA 22911 US
Baseline Brand NameMICROAIRE
Baseline Generic NameHIGH-SPEED DRILL
Baseline Model No6130
Baseline Catalog No6130
Baseline IDNA
Baseline Device FamilyDRILL
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK955591
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2004-08-12

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