BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUMA DESENSITIZER POWER GEL

    MDR report key: 3866874 · Received June 11, 2014

    Report

    Report Number
    9610902-2014-00026
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    March 1, 2014
    Report Date
    May 9, 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
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AS ALLOWED BY EXEMPTION# (B)(4), (B)(6) (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.

    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. ON (B)(6) 2014 NARRATIVE: DEVICE EVALUATION FROM SAME LOT.

    Description of Event or Problem · 1

    THIS INCIDENT OCCURRED IN (B)(6) (B)(6) 2014 UNCONTROLLED EXTRUSION. THE DENTIST REPLIED TO A RECALL NOTIFICATION LETTER WITH THE A FAX CONTAINING THE FOLLOWING INFORMATION: WE HAD EXPERIENCED THE "SUDDEN EXPULSION" OF THE GEL FROM THE SYRINGE ONE TIME ONLY, BUT HAD ATTRIBUTED IT TO MY OWN "OVERLY FORCEFUL" (PERHAPS) PRESSURE ON THE PLUNGER. FORTUNATELY MY PATIENT, STAFF, AND MYSELF HAD SAFETY GLASSES ON AND THE RUBBER DAM CONTAINED THE EXCESS GEL WITH NO SEQUELA. ON (B)(6) 2014 SPOKE TO ASSISTANT AT OFFICE. SHE STATED THAT THEY HAD A PARTIAL KIT REMAINING. IT CONTAINS THE SYRINGE FROM THE INCIDENT. SHE SAID THAT ABOUT 1/2 OF THE CONTENT OF THE SYRINGE CAME OUT IN THAT INCIDENT. SHE SAID THE INCIDENT OCCURRED SOME TIME IN (B)(6) 2014, BUT WAS NOT EXACTLY SURE OF THE DATE. SHE CONFIRMED THAT NO INJURIES OCCURRED DURING THIS INCIDENT. ARRANGED FOR PICKUP AND REPLACEMENT.

    Description of Event or Problem · 1

    THIS INCIDENT OCCURRED IN (B)(6). (B)(6) 2014 UNCONTROLLED EXTRUSION. THE DENTIST REPLIED TO A RECALL NOTIFICATION LETTER WITH THE A FAX CONTAINING THE FOLLOWING INFORMATION: WE HAD EXPERIENCED THE "SUDDEN EXPULSION" OF THE GEL FROM THE SYRINGE ONE TIME ONLY, BUT HAD ATTRIBUTED IT TO MY OWN "OVERLY FORCEFUL" (PERHAPS) PRESSURE ON THE PLUNGER. FORTUNATELY MY PATIENT, STAFF, AND MYSELF HAD SAFETY GLASSES ON AND THE RUBBER DAM CONTAINED THE EXCESS GEL WITH NO SEQUELAE. (B)(6) 2014 SPOKE TO ASSISTANT AT OFFICE. SHE STATED THAT THEY HAD A PARTIAL KIT REMAINING. IT CONTAINS THE SYRINGE FROM THE INCIDENT. SHE SAID THAT ABOUT ½ OF THE CONTENT OF THE SYRINGE CAME OUT IN THAT INCIDENT. SHE SAID THE INCIDENT OCCURRED SOME TIME IN (B)(6) 2014, BUT WAS NOT EXACTLY SURE OF THE DATE. SHE CONFIRMED THAT NO INJURIES OCCURRED DURING THIS INCIDENT. ARRANGED FOR PICKUP AND REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344627 GLUMA DESENSITIZER POWER GEL VARNISH, CAVITY LBH HERAEUS KULZER GMBH 010103

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention