BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUMA DESENSITIZER POWERGEL

    MDR report key: 3759706 · Received April 18, 2014

    Report

    Report Number
    9610902-2014-00004
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 20, 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
    TN, US
    Reporter Occupation
    DENTAL HYGIENIST

    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. THE DEVICE WAS RETURNED BY THE USER FOR TESTING. TESTED THE EXTRUSION PERFORMANCE OF THE SYRINGES. VISUALLY EXAMINED THE EXTRUDED MATERIAL. EXTRUSION PERFORMANCE NOT AS EXPECTED. SEE ATTACHED EVALUATION. CHANGES TO SYRINGE WERE IMPLEMENTED. THE LOW END OF THE VISCOSITY RANGE APPEARS TO BE INCOMPATIBLE WITH THIS NEW SYRINGE DESIGN. (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. (B)(4). THE LOW END OF THE VISCOSITY RANGE APPEARS TO BE INCOMPATIBLE WITH THIS NEW SYRINGE DESIGN.

    Description of Event or Problem · 1

    DENTAL STAFF MEMBER CALLED BECAUSE WHEN SHE WENT TO USE THE NEW SYRINGE OF GDPG, IT WAS DIFFICULT TO EXTRUDE. SHE SAID IT DID NOT COME OUT WHEN SHE FIRST PUSHED THE PLUNGER. SHE REMOVED IT FROM THE PATIENT'S MOUTH AND THEN SHE PUSHED A LITTLE HARDER AND ALMOST ALL OF IT SHOT OUT ONTO THE TRAY SHE WAS USING. SHE SAID THAT WHEN SHE LOOKED AT THE GEL THAT WAS INITIALLY EXTRUDED, IT WAS HARD AND CRUSTY.

    Description of Event or Problem · 1

    DENTAL STAFF MEMBER CALLED BECAUSE WHEN SHE WENT TO USE THE NEW SYRINGE OF GDPG, IT WAS DIFFICULT TO EXTRUDE. SHE SAID IT DID NOT COME OUT WHEN SHE FIRST PUSHED THE PLUNGER. SHE REMOVED IT FROM THE PATIENT'S MOUTH AND THEN SHE PUSHED A LITTLE HARDER AND ALMOST ALL OF IT SHOT OUT ONTO THE TRAY SHE WAS USING. SHE SAID THAT WHEN SHE LOOKED AT THE GEL THAT WAS INITIALLY EXTRUDED, IT WAS HARD AND CRUSTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237292 GLUMA DESENSITIZER POWERGEL VARNISH, CAVITY LBH HERAEUS KULZER GMBH 45/010103

    Patients

    Seq Age Sex Outcome Treatment
    1