BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AD SURGICAL EXPLORER AND PROBE

    MDR report key: 11783265 · Received May 5, 2021

    Report

    Report Number
    MW5101208
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Date of Event
    May 3, 2021
    Report Date
    May 4, 2021
    Manufacturer
    AD SURGICAL
    Product Code
    EIX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    SINGLE USE ITEM AT THE WEBSITE HTTPS://WWW.AD-SURGICAL.COM/D002-008-P-EXPLORER-AND-PROBE/ IS AN ITEM THAT TOUCHES ORAL MUCOSA. SPECIFICALLY, THE BLACK AND WHITE PORTION MAY BE INSERTED INTO THE PERIODONTAL POCKET. COULD NOT GET RESPONSE FROM COMPANY IF ITEM IS HIGH LEVEL DISINFECTED PRIOR TO PACKAGING. A STERILE OPTION D002-009 IS AVAILABLE BUT D002-008 IS NOT STERILE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675878 AD SURGICAL EXPLORER AND PROBE EXPLORER AND PROBE EIX AD SURGICAL #D002-008-P

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Other