BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUMA DESENSITIZER POWER GEL

    MDR report key: 3853827 · Received June 6, 2014

    Report

    Report Number
    9610902-2014-00013
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    February 1, 2014
    Report Date
    May 6, 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
    GA, 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). THE OFFICE USED ONLY COTTON ROLLS FOR ISOLATION, WHICH IS INADEQUATE. BY IMMEDIATELY RINSING PATIENT THE DENTIST PREVENTED TISSUE INJURY. 09/09/2014 - DEVICE EVALUATION FROM SAME LOT.

    Additional Manufacturer Narrative · 1

    (B)(4) (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HERAEUS KULZER (B)(4) (THE MANUFACTURER). 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 HAS NOT BEEN RETURNED BY CUSTOMER. DIRECTIONS FOR USE INDICATE RUBBER DAM USE IS REQUIRED. THE OFFICE USED ONLY COTTON ROLLS FOR ISOLATION, WHICH IS INADEQUATE. BY IMMEDIATELY RINSING PATIENT THE DENTIST PREVENTED TISSUE INJURY.

    Description of Event or Problem · 1

    UNCONTROLLED EXTRUSION INTO PATIENTS MOUTH. SPOKE TO ASSISTANT WHEN CALLING ON THE RECALL FOR SAID PRODUCT. SHE STATED THAT THEY HAD A SYRINGE THAT SQUIRTED 1/2 OF ITS CONTENT INTO THE PATIENT'S MOUTH. SHE SAID THAT THEY USED COTTON ROLL ISOLATION. SHE SAID THAT THE GEL WENT ONTO THE PATIENT'S BUCCAL MUCOSA AND GINGIVA. SHE SAID THAT THEY IMMEDIATELY RINSED OFF THE TISSUES UNTIL ALL OF THE GEL WAS GONE. SHE SAID THAT THE PATIENT DID NOT REPORT ANY ADVERSE EFFECTS. THEY HAVE THE SYRINGE WHICH IS MOSTLY EMPTY AND 2 MORE SYRINGES.

    Description of Event or Problem · 1

    UNCONTROLLED EXTRUSION INTO PATIENTS MOUTH SPOKE TO ASSISTANT WHEN CALLING ON THE RECALL FOR SAID PRODUCT. SHE STATED THAT THEY HAD A SYRINGE THAT SQUIRTED 1/2 OF ITS CONTENT INTO THE PATIENT'S MOUTH. SHE SAID THAT THEY USED COTTON ROLL ISOLATION. SHE SAID THAT THE GEL WENT ONTO THE PATIENT'S BUCCAL MUCOSA AND GINGIVA. SHE SAID THAT THEY IMMEDIATELY RINSED OFF THE TISSUES UNTIL ALL OF THE GEL WAS GONE. SHE SAID THAT THE PATIENT DID NOT REPORT ANY ADVERSE EFFECTS. THEY HAVE THE SYRINGE WHICH IS MOSTLY EMPTY AND 2 MORE SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332739 GLUMA DESENSITIZER POWER GEL VARNISH, CAVITY LBH HERAEUS KULZER GMBH 010103

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR