BEUDAMED
    FDA Adverse Event Other Summary report: N

    LARES 557 ULTRALITE HANDPIECE

    MDR report key: 3001473 · Received March 4, 2013

    Report

    Report Number
    2916440-2013-00001
    Event Type
    Other
    Date Received
    March 4, 2013
    Date of Event
    February 22, 2013
    Report Date
    March 1, 2013
    Manufacturer
    LARES RESEARCH
    Product Code
    EFB
    PMA / PMN Number
    K780038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVOLVED IN INCIDENT WAS FOR DEMONSTRATION ONLY. NO ABNORMAL OPERATION WAS DETECTED BY THE REP PRESENT.

    Description of Event or Problem · 1

    AT 11:56 AM SATURDAY, (B)(6) 2013, DR (B)(6) OF (B)(6) CAME UP TO OUR BOOTH AT THE HANDPIECE DEMONSTRATION STAND ATTENDED BY A LARES REP. WE NORMALLY ALLOW DENTISTS TO EXPERIENCE THE PERFORMANCE OF OUR HANDPIECES BY HANDING THEM A LARGE PIECE OF BONE TO CUT ON. INSTEAD, THE DENTIST PULLED A COPPER PENNY OUT OF HIS POCKET AND BEGAN CUTTING IT EXTENSIVELY WITH ONE OF OUR HANDPIECES. SOMEHOW (EITHER HE LOOKED AWAY FROM WHAT HE WAS CUTTING, SLIPPED OR CUT THROUGH THE PENNY INTO HIS FINGER) THE DENTIST MANAGED TO CUT HIMSELF ON THE FINGER WHICH LED TO SIGNIFICANT BLEEDING. WE IMMEDIATELY GAVE THE DENTIST SOME NAPKINS AND PAPER TOWELS TO STOP THE BLEEDING; AN EXHIBITOR FROM THE BOOTH NEXT TO US GAVE HIM A BAND-AID WHICH HE APPLIED TO THE WOUND. A REP USED SOME (B)(6) WIPES TO CLEAN OFF ALL THE BLOOD ON THE DEMONSTRATION STAND. THE DENTIST SEEMED OK AND WAS NOT ANGRY OR SHAKEN UP. HOWEVER, WE DID WATCH HIM CAREFULLY AS HE REMAINED AT OUR DEMONSTRATION STAND AND AGAIN BEGAN TO CUT ON THE SAME PENNY FROM HIS POCKET. HE THEN STOPPED, PUT THE HANDPIECE BACK IN ITS NEST AND REPORTED TO OUR REP THAT HE FELT DIZZY. WE THEN ASKED HIM TO STEP INTO OUR BOOTH AND TO SIT DOWN IN ONE OF THE CHAIRS. HE DID SO WILLINGLY AND I GUIDED HIM INTO THE CHAIR WITH MY HANDS ON BOTH HIS SHOULDERS. AS SOON AS HE SAT DOWN HIS HEAD FELL TO HIS CHEST AS HE SEEMED TO FAINT AND I KEPT HIM SITTING IN THE CHAIR WITH MY HANDS STILL ON BOTH SHOULDERS. A REP WENT IMMEDIATELY TO THE EXHIBIT MGR'S OFFICE (IN PLAIN SIGHT ABOUT 50 FEET FROM OUR BOOTH) TO GET MEDICAL ASSISTANCE. THE DENTIST WAS IN AND OUT OF HIS FAINT AND AN ADD'L REP CAME OVER AND ASSISTED IN ASKING THE DENTIST WHAT MEDICATIONS HE MIGHT BE ON AND DOCUMENTING SAME ON A PIECE OF PAPER (PROVIDED TO PARAMEDICS UPON THEIR ARRIVAL). VERY QUICKLY THE EXHIBIT MGR ARRIVED AT OUR BOOTH AND DIRECTED US TO CAREFULLY LOWER THE DENTIST TO THE CARPET FLOOR OF OUR BOOTH TO LAY HIM DOWN AND PUT HIS KNEES UP. HE ALSO CHECKED HIS PULSE AND ASKED HIM ABOUT ANY CURRENT MEDICAL CONDITIONS, AND REVIEWED THE LIST OF MEDICATIONS THAT HAD BEEN PREPARED. THE DENTIST MENTIONED HE HAD RECENTLY HAD A STENT PUT IN. HIS LIST OF MEDICATIONS WAS EXTENSIVE. MEDICAL STAFF FINALLY ARRIVED AND CHECKED OUT THE DENTIST. AFTER 15 OR SO MINUTES, THEY LIFTED HIM UP INTO A WHEELCHAIR AND TRANSPORTED HIM AWAY TO TAKE HIM TO THE HOSP. A COUPLE OF HOURS LATER THE SAME DAY, THE DENTIST CAME BY OUR BOOTH AND SAID HE WAS FINE AND APOLOGIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90775 LARES 557 ULTRALITE HANDPIECE HIGH-SPEED DENTAL HANDPIECE EFB LARES RESEARCH 557

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK