inforMED
MalfunctionEJL

BRASSELER USA CARBIDE BUR

Received Nov 30, 2017 · Event occurred Oct 31, 2017

Report 1032227-2017-00006 · MDR key 7071875

Device

Generic name

Dental Carbide Bur

Model number

H7.33.008

Catalog number

000193U7

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

78 YR

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

NO PRODUCT WAS RETURNED. BURS FROM INVENTORY WERE CHECKED. ALL BURS CHECKED WERE FOUND TO MEET SPECIFICATIONS. UNABLE TO DETERMINE CAUSE OF BUR WALK OUT, BUT MAY BE DUE TO A WORN HANDPIECE COLLET. THIS IS AN ISOLATED OCCURRENCE.

Description of Event or Problem

DOCTOR NOTED BUR WOULD NOT STAY IN HANDPIECE AND A PATIENT HAD ONE GO DOWN THEIR THROAT. PATIENT WAS NOT SENT FOR X-RAYS INITIALLY BECAUSE WAS BREATHING FINE AND NO ISSUES AFTER INCIDENT. BUR WAS FOUND IN STOOL LATER THE NEXT DAY. FOLLOW UP VISIT TO DENTAL OFFICE ON (B)(6) 2017 NOTED PATIENT WAS DOING FINE.