BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROUND DIAMOND BUR, LONG

    MDR report key: 79100 · Received March 20, 1997

    Report

    Report Number
    1017294-1997-00001
    Event Type
    Malfunction
    Date Received
    March 20, 1997
    Date of Event
    March 4, 1997
    Report Date
    March 13, 1997
    Manufacturer
    LINVATEC CORP.
    Product Code
    HTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 3/4/97, CO RECEIVED A COMPLAINT FROM DISTRIBUTOR THAT THE ROUND DIAMOND BUR, LONG, CATALOG #5092-266, LOT#00043870, WAS MISLABELED. THE PRODUCT WAS ACTUALLY A ROUND DIAMOND BUR, EXTRA LONG, CATALOG #5093-266. CO CONFIRMED THAT THE PRODUCT WAS ACTUALLY A ROUND DIAMOND BUR, EXTRA LONG, CATALOG # 5093-266, ON 3/11/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROUND DIAMOND BUR, LONG STERILE BURS HTT LINVATEC CORP. 00509226600 00043870

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN