BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAVA C.O.S. POWDER

    MDR report key: 2496030 · Received March 16, 2012

    Report

    Report Number
    3005174370-2012-00004
    Event Type
    Injury
    Date Received
    March 16, 2012
    Date of Event
    October 13, 2011
    Report Date
    March 1, 2012
    Manufacturer
    3M ESPE DENTAL PRODUCTS
    Product Code
    NOF
    PMA / PMN Number
    K073199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THE LAVA COS DEVICE (OPTICAL IMPRESSION SYSTEM) ITSELF WAS EXEMPT FROM FILING, THE 510K (K073199) INCLUDED DETAILED INFO ON THE LAVA C.O.S. POWDER AND THE PURPOSE OF THE FILING WAS TO GAIN CLEARANCE FOR THE POWDER AND THE POWDER DELIVERY SYSTEM. NO OTHER REPORTS OF ANY ADVERSE HEALTH EFFECTS FOLLOWING USE OF THE SUBJECT POWDER HAVE BEEN REPORTED TO 3M ESPE. FOLLOW-UP REPORTS WILL BE SUBMITTED IF 3M ESPE BECOMES AWARE OF ANY OTHER INFO PERTINENT TO THIS EVENT.

    Description of Event or Problem · 1

    ON MARCH 1, 2012, 3M ESPE WAS INFORMED THAT ON (B)(6) 2011, A (B)(6) FEMALE, PT HAD AN INTRA-ORAL DENTAL SCAN PERFORMED USING 3M ESPE LAVA POWER FOR COS. THREE DAYS LATER, THE PT NOTED SYMPTOMS INVOLVING HER LEFT VOCAL CORD, WHICH HAS SUBSEQUENTLY BEEN CATEGORIZED AS A PARALYZED VOCAL CORD. BASED ON INFO PROVIDED BY THE PT'S DENTIST, MEDICAL PROFESSIONALS DO NOT KNOW THE CAUSE OF THE PARALYSIS AND FEEL THAT IT MAY TAKE UP TO ONE YEAR TO HEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAVA C.O.S. POWDER IMPRESSION MATERIAL NOF 3M ESPE DENTAL PRODUCTS

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Disability