BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY-SCHEIN PRECISION TORQUE

    MDR report key: 1821441 · Received August 27, 2010

    Report

    Report Number
    2916440-2010-00002
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    July 22, 2010
    Report Date
    August 19, 2010
    Manufacturer
    LARES RESEARCH INC.
    Product Code
    EFB
    PMA / PMN Number
    K780038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL; RESULTS: INDICATIONS ARE THAT THE USER DID NOT REALIZE (IDENTIFY) DEVICE CONDITION AND DISCONTINUE USE PRIOR TO CONTACT WITH PT TISSUE. CONCLUSIONS: THE PRIMARY CHUCK NUT FRACTURE WENT UNNOTICED AND SUBSEQUENT TIGHTENING EXPANDED THE REMAINING NUT RETENTION OUTSIDE DIAMETER TO A LEVEL OF STRAIN THAT PROMPTED A SECONDARY AND FINAL RETENTION SKIRT FRACTURE ALLOWING THE NUT QUADRANT TO DISLODGE FROM THE HANDPIECE. THE INTERIM RUBBING OF THE DAMAGED CHUCK NUT ON THE HEAD OPENING GENERATED THE HEAT THAT CONTACTED THE PT.

    Description of Event or Problem · 1

    (B)(4) - THE PIECE OF THE HANDPIECE THAT HOLDS THE BUR IN PLACE BROKE DURING USE AND BURNED THE PT'S CHEEK. THE BURN WAS VERY SMALL AND THE PT DID NOT REQUIRE MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HENRY-SCHEIN PRECISION TORQUE HIGH-SPEED DENTAL HANDPIECE EFB LARES RESEARCH INC. 10056

    Patients

    Seq Age Sex Outcome Treatment
    1