BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUMA DESENSITIZER POWERGEL

    MDR report key: 3840575 · Received May 30, 2014

    Report

    Report Number
    9610902-2014-00010
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Report Date
    May 1, 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
    OH, US
    Reporter Occupation
    DENTAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    AS ALLOWED BY EXEMPTION# (B)(4),(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 HAS NOT BEEN RETURNED BY THE CUSTOMER. PICKUP WAS CANCELLED BY CUSTOMER. ON (B)(6) 2014 - DEVICE EVALUATION FROM SAME LOT.

    Additional Manufacturer Narrative · 1

    AS ALLOWED BY EXEMPTION# (B)(4). (B)(6) 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. METHOD AND CONCLUSION - THE DEVICE HAS NOT BEEN RETURNED BY THE CUSTOMER. PICKUP WAS CANCELLED BY CUSTOMER. RESULTS AND CONCLUSION - EVALUATION OF MALFUNCTION ROOT CAUSE IN PROGRESS. DEVICE NOT YET RETURNED.

    Description of Event or Problem · 1

    SPOKE TO DENTAL OFFICE STAFF MEMBER. SHE SAID THAT THEY HAVE 6 OPEN SYRINGES LOT 010103. SHE STATED THAT THEY HAVE HAD THE UNCONTROLLED EXTRUSION FOR SOME TIME AND THAT THE DENTIST DOES NOT EXTRUDE IN THE PATIENTS MOUTH FOR THIS REASON. SHE SAID THAT THEY HAD BEEN CONSIDERING SWITCHING TO GD LIQUID FOR THIS REASON.

    Description of Event or Problem · 1

    SPOKE TO DENTAL OFFICE STAFF MEMBER. SHE SAID THAT THEY HAVE 6 OPEN SYRINGES LOT 010103. SHE STATED THAT THEY HAVE HAD THE UNCONTROLLED EXTRUSION FOR SOME TIME AND THAT THE DENTIST DOES NOT EXTRUDE IN THE PATIENT'S MOUTH FOR THIS REASON. SHE SAID THAT THEY HAD BEEN CONSIDERING SWITCHING TO GD LIQUID FOR THIS REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318851 GLUMA DESENSITIZER POWERGEL VARNISH LBH HERAEUS KULZER GMBH 48/010103

    Patients

    Seq Age Sex Outcome Treatment
    1