DIAMOND BUR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-01 for DIAMOND BUR manufactured by Unk.

Event Text Entries

[140800526] Pt was having dental procedure when diamond bur lead came off and required intervention by staff to avoid swallowing of bur. (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5085511
MDR Report Key8474017
Date Received2019-04-01
Date of Report2019-03-28
Date of Event2019-03-07
Date Added to Maude2019-04-02
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameDIAMOND BUR
Generic NameDENTAL INSTRUMENT, DIAMOND
Product CodeDZP
Date Received2019-04-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-04-01

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