BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AD SURGICAL EXPLORER AND PROBE

    MDR report key: 11313391 · Received February 10, 2021

    Report

    Report Number
    MW5099337
    Event Type
    Malfunction
    Date Received
    February 10, 2021
    Report Date
    February 8, 2021
    Manufacturer
    AD SURGICAL /APPLIED DENTAL INC. DBA AD SURGICAL
    Product Code
    EIX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    (B)(6) IS CURRENTLY SELLING NON-STERILE SINGLE USE BDS KITS (EXPLORER AND PROBES). THE KITS ARE DESIGNATED TO BE USED FOR SIMPLE EXAMS, EMERGENCIES AND OTHER TYPES OF APPOINTMENTS. THE ISSUE IS THESE ITEMS ARE CLASSIFIED AS SEMI-CRITICAL ITEMS AND REQUIRE A STERILIZATION PROCESS BEFORE USE ON PATIENTS. THE COMPANY HAS STATED THEY ARE NON-STERILE AND THEY DO NOT PROVIDE STERILIZATION INSTRUCTION AS REQUIRED BY CDC. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208346 AD SURGICAL EXPLORER AND PROBE PROBE, PERIODONTIC EIX AD SURGICAL /APPLIED DENTAL INC. DBA AD SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1