BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYGENIC

    MDR report key: 7808766 · Received August 23, 2018

    Report

    Report Number
    2416455-2018-08239
    Event Type
    Malfunction
    Date Received
    August 23, 2018
    Date of Event
    May 29, 2018
    Report Date
    September 21, 2018
    Manufacturer
    COLTENE WHALEDENT INC.
    Product Code
    EEF
    UDI-DI
    D661H007500
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER STATES THEY RECEIVED (1) BOX OF H00750 FRAMED FLEXI-DAM, LOT 060J, THAT CONTAINS FRAMED FLEXI-DAM THAT IS LOOSE FROM THE FRAME AND RUPTURES WHEN TRYING TO PUT THEM IN PLACE. THE CUSTOMER DID NOT RETURN ANY PRODUCT FOR ANALYSIS. COMPLAINT ANALYSIS: COMPLAINT HISTORY ANALYSIS SHOWS NO ADDITIONAL COMPLAINTS FOR THE FRAME COMING LOOSE FROM THIS BATCH. THE INVENTORY ANALYSIS SHOWS NO REMAINING PRODUCT IN STOCK OF THIS LOT NUMBER. SAP SHOWS STOCK OF THIS BATCH, CONTAINING 2,280 BOXES OF, FRAMED FLEXI-DAM WAS DEPLETED 06/07/2017. ROOT CAUSE ANALYSIS: WHY? CUSTOMER IS DISSATISFIED WITH THE ADHESION OF THE FLEXI-DAM TO THE FRAME. WHY? THE FLEXI-DAM IS SEPARATING FROM THE EDGES OF THE FRAME. WHY? POOR ADHESION IS OBSERVED WHERE THE FLEXI-DAM IS GLUED TO THE FRAME. WHY? A CHANGE IN MANUFACTURING PROCESS OR MATERIALS BY (B)(4) MAY BE TO BLAME FOR THIS CHANGE IN ADHESION PROPERTIES. WHY? IT APPEARS TO BE AN ISOLATED INCIDENT OF A KNOWN ISSUE THAT HAS BEEN ADDRESSED THROUGH A CAPA GENERATED INTERNALLY AT THEIR FACILITY BY THE SUPPLIER. CAPA ASSESSMENT: CAPA NOT REQUIRED AT THIS TIME. THIS LOT WILL CONTINUE TO BE MONITORED FOR FURTHER OCCURRENCES.

    Description of Event or Problem · 1

    DENTAL DAM IS COMING LOOSE FROM FRAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652310 HYGENIC DENTAL FRAMED DAM EEF COLTENE WHALEDENT INC. 060J D661H007500

    Patients

    Seq Age Sex Outcome Treatment
    1