HALL SURGICAL BUR GUARD 00-1375-012-00

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 1999-07-08 for HALL SURGICAL BUR GUARD 00-1375-012-00 manufactured by Linvatec Corp..

Event Text Entries

[141769] Surgeon reported the bur guard to be 'loose' which resulted in a 'small tear' on the patient's lip. No medical intervention required except the application of antibiotic ointment. The scrub nurse reported that there was 'no play in the bur guard. ' patient was seen by a plastic surgeon. No surgical intervention required.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1017294-1999-00025
MDR Report Key231545
Report Source05,06
Date Received1999-07-08
Date of Report1999-06-08
Date of Event1999-06-07
Report Date1999-07-07
Date Mfgr Received1999-06-08
Device Manufacturer Date1994-06-01
Date Added to Maude1999-07-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHALL SURGICAL BUR GUARD
Generic NameBUR GUARD
Product CodeHXY
Date Received1999-07-08
Returned To Mfg1999-06-16
Model NumberNA
Catalog Number00-1375-012-00
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key224442
ManufacturerLINVATEC CORP.
Manufacturer Address11311 CONCEPT BLVD. LARGO FL 33773 US


Patients

Patient NumberTreatmentOutcomeDate
10 1999-07-08

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