BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUMA DESENSITIZER POWER GEL

    MDR report key: 3849529 · Received June 4, 2014

    Report

    Report Number
    9610902-2014-00012
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Report Date
    May 5, 2014
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    LBH
    PMA / PMN Number
    K093575
    Removal / Correction Number
    1925223-04/23/14-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    DENTAL ASSISTANT

    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 TO BE COMPLIANT WITH 21 CFR PART 803 AND OUT OF AN ABUNDANCE OF CAUTION. DEVICE WAS RETURNED EMPTY. EVALUATION OF MALFUNCTION ROOT CAUSE IN PROGRESS. (B)(4) 2014 NARRATIVE - DEVICE EVALUATION FROM SAME LOT. PLEASE SEE ATTACHED ROOT CAUSE REPORT AND CAPA REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE'RE REPORTING IT TO BE COMPLIANT WITH 21 CFR PART 803 AND OUT OF AN ABUNDANCE OF CAUTION. EVALUATION OF MALFUNCTION ROOT CAUSE IN PROGRESS.

    Description of Event or Problem · 1

    WHEN CALLING OFFICE REGARDING A CURRENT RECALL ON SAID PRODUCT I SPOKE TO THE ASSISTANT. SHE SAID THAT THEY HAVE HAD THE EXTRUSION ISSUE AND WHEN THE DENTIST TRIED TO EXTRUDE IT SHE FELT THE RESISTANCE AND THEN IT SHOT UP HER ARM ON HER LAB COAT. SHE SQUIRTED IT OUT ON HER GLOVE FIRST AND THAT IS HOW IT GOT ALL OVER HER LAB COAT. SHE SAID THAT THE SYRINGE IS EMPTY, BUT IT IS LOT#010103.

    Description of Event or Problem · 1

    WHEN CALLING OFFICE REGARDING A CURRENT RECALL ON SAID PRODUCT I SPOKE TO THE ASSISTANT. SHE SAID THAT THEY HAVE HAD THE EXTRUSION ISSUE AND WHEN THE DENTIST TRIED TO EXTRUDE IT SHE FELT THE RESISTANCE AND THEN IT SHOT UP HER ARM ON HER LAB COAT. SHE SQUIRTED IT OUT ON HER GLOVE FIRST AND THAT IS HOW IT GOT ALL OVER HER LAB COAT. SHE SAID THAT THE SYRINGE IS EMPTY, BUT IT IS LOT #010103.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326520 GLUMA DESENSITIZER POWER GEL VARNISH, CAVITY LBH HERAEUS KULZER GMBH 010103

    Patients

    Seq Age Sex Outcome Treatment
    1