BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUMA DESENSITIZER POWER GEL

    MDR report key: 3875302 · Received June 16, 2014

    Report

    Report Number
    9610902-2014-00030
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    December 1, 2013
    Report Date
    May 19, 2014
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    LBH
    PMA / PMN Number
    K093575
    Removal / Correction Number
    1925223-04/23/14-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 TO BE COMPLIANT WITH 21 CFR PART 803 AND OUT OF AN ABUNDANCE OF CAUTION. (B)(4).

    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. METHOD AND CONCLUSION: THE DEVICE HAS NOT BEEN RETURNED BY THE CUSTOMER. RESULTS AND CONCLUSION: EVALUATION OF MALFUNCTION ROOT CAUSE IN PROGRESS. ACTUAL DEVICE NOT EVALUATED.

    Description of Event or Problem · 1

    ASSISTANT RETURNED CALL CONCERNING RECALL OF SAID PRODUCT. SHE SAID THEY HAD IT SHOOT DOWN A PATIENT'S THROAT SOMETIME IN DECEMBER. SHE COULD REMEMBER NO SPECIFIC DETAILS WITH REGARD TO WHICH PATIENT. THE ASSISTANT SAID THE PATIENT WAS RINSED OUT IMMEDIATELY AND THE PATIENT CALLED BACK THE NEXT MORNING TO REPORT BLISTERS IN THROAT. THE ASSISTANT INSTRUCTED THE PATIENT TO RINSE WITH WARM SALT WATER AND TO CALL BACK IF THE CONDITION WORSENED OR DID NOT IMPROVE IN THE NEXT WEEK. THE PATIENT DID NOT CALL BACK A SECOND TIME. THE ASSISTANT STATED THEY USE COTTON ROLL ISOLATION AND DO NOT USE A RUBBER DAM WHEN APPLYING SAID PRODUCT.

    Description of Event or Problem · 1

    ASSISTANT RETURNED CALL CONCERNING RECALL OF SAID PRODUCT. SHE SAID THEY HAD IT SHOOT DOWN A PATIENT'S THROAT SOMETIME IN DECEMBER. SHE COULD REMEMBER NO SPECIFIC DETAILS WITH REGARD TO WHICH PATIENT. THE ASSISTANT SAID THE PATIENT WAS RINSED OUT IMMEDIATELY AND THE PATIENT CALLED BACK THE NEXT MORNING TO REPORT BLISTERS IN THROAT. THE ASSISTANT INSTRUCTED THE PATIENT TO RINSE WITH WARM SALT WATER AND TO CALL BACK IF THE CONDITION WORSENED OR DID NOT IMPROVE IN THE NEXT WEEK. THE PATIENT DID NOT CALL BACK A SECOND TIME. THE ASSISTANT STATED THEY USE COTTON ROLL ISOLATION AND DO NOT USE A RUBBER DAM WHEN APPLYING SAID PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352938 GLUMA DESENSITIZER POWER GEL VARNISH, CAVITY LBH HERAEUS KULZER GMBH 010103

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention