BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUMA DESENSITIZER POWERGEL

    MDR report key: 2931476 · Received January 17, 2013

    Report

    Report Number
    9610902-2013-00023
    Event Type
    Injury
    Date Received
    January 17, 2013
    Report Date
    December 12, 2012
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    LBH
    PMA / PMN Number
    K093575
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE'RE REPORTING IT OUT OF AN ABUNDANCE CAUTION TO BE COMPLIANT WITH 21 CFR. CONCLUSION - THE OFFICE WAS USING METAL APPLICATOR TIPS THAT ARE CONTRAINDICATED IN THE DIRECTIONS FOR USE. THE DIRECTIONS STATE, "GLUMA DESENSITIZER POWERGEL MUST NOT COME INTO CONTACT WITH METAL (E.G. CANNULAE OR OTHER APPLICATION AIDS.)"

    Description of Event or Problem · 1

    THIS IS THE SECOND OF FOUR REPORTS FROM THE SAME OFFICE FOR ONE DEVICE. SALES REP SENT IN A COMPLAINT AND REQUEST TO RETURN SAMPLE. SPOKE TO ASSISTANT AT THE DENTAL OFFICE. SHE SAID THAT THEY HAD 4 PTS RETURN AFTER THEY USED THE GDPG. SHE SAID THEY REPLACED THE FILLINGS AND USED THE GD LIQUID FOR THE REPLACEMENT AND THE SENSITIVITY AND ITCHING HAS GONE AWAY. ASKED HER FOR PT DETAILS. SHE SAID SHE ONLY REMEMBERED 2 OF THE 4 PTS. SHE SAID THAT ALL OF THE PTS WHO HAVE COMPLAINED HAVE HAD THEIR RESTORATIONS REPLACED AND THAT ALL ARE FINE NOW. PT 3 - NO DETAILS. ASKED FOR THE TREATMENT PROTOCOL AND SHE SAID THAT THEY USE COTTON ROLL ISOLATION, THEY PLACE THE GDPG AFTER THE ETCH STEP, THEY LEAVE ON FOR ABOUT 30 SECONDS, THEN RINSE AND DRY. THE SALES REP REPORTED THAT THE OFFICE IS USING THE METAL ETCHING TIPS EVEN THOUGH THE DIRECTION SPECIFICALLY SAYS NOT TO USE THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26671 GLUMA DESENSITIZER POWERGEL LBH VARNISH, CAVITY LBH HERAEUS KULZER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention