HENRY SCHEIN 9004357

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-14 for HENRY SCHEIN 9004357 manufactured by Prima Dental.

Event Text Entries

[102399199] During a composite filling procedure on the distal end of tooth#2, the bur came out of a dental handpiece and the patient swallowed the finishing bur. The dentist did not use a dental dam during this procedure. The patient was instructed to go for an x-ray; however, patient refused to get an x-ray taken.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2411236-2018-00006
MDR Report Key7339178
Date Received2018-03-14
Date of Report2018-02-20
Date of Event2018-02-13
Date Facility Aware2018-02-20
Report Date2018-03-14
Date Reported to FDA2018-03-14
Date Reported to Mfgr2018-03-14
Date Added to Maude2018-03-14
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHENRY SCHEIN
Generic NameCARBIDE BUR T&F 12 BLADE
Product CodeEJL
Date Received2018-03-14
Catalog Number9004357
OperatorDENTIST
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerPRIMA DENTAL
Manufacturer AddressSTEPHENSON DRIVE BUSINESS PARK GLOUCESTER, GL2 2AG UK GL2 2AG


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-03-14

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