BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLEMINI LUX 4500 BR

    MDR report key: 2824107 · Received October 10, 2012

    Report

    Report Number
    3003637274-2012-00048
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 17, 2012
    Report Date
    September 19, 2012
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EFB
    PMA / PMN Number
    K073478
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE HAS BEEN ANALYZED AT THE REPAIR DEPARTMENT AT (B)(4) AND AGAIN IN THE HEADQUARTER AT KAVO (B)(4). BOTH DEPARTMENTS TESTED THE HOLDING FORCE OF THE CHUCK WITH THE CORRESPONDING SPECIAL TOOL. IN BOTH CASES IT WAS NOT POSSIBLE TO FIND A DEVIATION FROM THE SPECIFICATION. THERE WAS NO FAULT FOUND AT THE HANDPIECE. AS THE ORIGINALLY USED BUR IS NOT AVAILABLE IT IS NOT POSSIBLE TO VERIFY WHETHER THE SHANK DIAMETER WAS WITHIN THE SPECIFICATION. DUE TO THE AVAILABLE FACTS IT IS LIKELY THAT THIS SHANK DIAMETER WAS TOO SMALL (COULD BE WORN OUT) AND HANCE IT FELL OFF DURING THE USE. (B)(4). KAVO DENTAL (B)(4) (THE MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF (B)(4) (THE IMPORTER).

    Description of Event or Problem · 1

    DURING A STANDARD TREATMENT THE BUR CAM LOOSE AND WAS SWALLOWED BY THE PT. HE WAS TAKEN TO HOSPITAL TO TAKE AN X-RAY OF THE STOMACH. THEY KEPT THE PT OVERNIGHT TO MAKE SURE BUR WAS PASSED. THE PT DID NOT RECEIVE ANY INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENTLEMINI LUX 4500 BR DENTAL HANDPIECE EFB KAVO DENTAL GMBH 4500 BR

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization