BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUMA DESENSITIZER POWER GEL

    MDR report key: 3872905 · Received June 13, 2014

    Report

    Report Number
    9610902-2014-00028
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 14, 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, 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. METHOD: ACTUAL DEVICE HAS NOT BEEN RECEIVED BACK BY THE MANUFACTURER. LABELING EVALUATION- THE DIRECTIONS STATE, "PROTECT MUCOUS MEMBRANES FROM CONTACT WITH THE PRODUCT USING A RUBBER DAM." STAFF REPORTED THAT NO ISOLATION METHOD WAS USED. WITHOUT PROPER ISOLATION THE USER EXPOSED THE SOFT TISSUES TO THE GLUMA DESENSITIZER. "THE DIRECTIONS ALSO STATES, GLUMA DPG MUST NOT BE USED IF THE NECESSARY PRECAUTIONS CANNOT BE TAKEN OR THE STIPULATED APPLICATION TECHNIQUE IS NOT POSSIBLE. IT ALSO STATES, ONLY TO BE USED BY DENTIST. THE DIRECTION FOR USE HAS ADEQUATE WARNING AGAINST EXPOSURE STATING, "IRRITATING TO SKIN. THE PRODUCT CONTAINS METHACRYLATE COMPOUNDS THAT MAY CAUSE SENSITIZATION BY SKIN CONTACT. GLUMA DESENSITIZER POWERGEL CONTAINS GLUTARDIALDEHYDE THAT MAY CAUSE LOCALIZED IRRITATION AND MAY CAUSE SENSITIZATION EITHER DIRECTLY OR THROUGH INHALATION. AVOID CONTACT WITH SKIN, IMMEDIATELY WASH WITH PLENTY OF WATER AND SOAP. (B)(4). ACTUAL DEVICE NOT AVAILABLE.

    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: ACTUAL DEVICE HAS NOT BEEN RECEIVED BACK BY THE MANUFACTURER. ACTUAL DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    UNCONTROLLED EXTRUSION INTO (B)(6) FEMALE PATIENTS MOUTH, TISSUE DISCOLORATION. (B)(6) 2014 RECEIVED A CALL IN RESPONSE TO THE RECALL LETTER OF SAID PRODUCT. THE PATIENT IS A STAFF MEMBER IN THE OFFICE. SHE SAID THAT THEY JUST RECEIVED THE GDPG AT THE BEGINNING OF (B)(6) . SHE SAID THAT SHE WANTED TO SEE HOW IT WORKED SO SHE APPLIED SOME TO HERSELF ON THE CERVICAL OF #6. SHE DID NOT USE ANY ISOLATION. SHE SAID THAT IT CAME OUT IN THE UNCONTROLLED MANNER AND GOT ALL OVER HER GINGIVA. SHE SAID THAT SHE RINSED IT OFF IMMEDIATELY. SHE SAID THAT THE TISSUES TURNED WHITISH, BUT SHE HAD NO OTHER SYMPTOMS. SHE SAID THAT THE COLOR RETURNED TO NORMAL IN 2 DAYS AND SHE IS COMPLETELY RECOVERED. SHE DID NOT TAKE ANY MEDICATION OR RECEIVE ANY TREATMENT. ARRANGED FOR THE PICKUP AND REPLACEMENT. THIS IS A REPORTABLE MALFUNCTION ACCORDING TO 21 CFR 803.50, IF THE MALFUNCTION WERE TO RECUR. THIS IS A REPORTABLE MALFUNCTION AS THIS MALFUNCTION COULD CAUSE SERIOUS INJURY IF THE MATERIAL SHOOTS INTO THE PATIENT'S MOUTH OR OTHER AREAS OF THE BODY TO WHICH IT IS NOT INTENDED.

    Description of Event or Problem · 1

    UNCONTROLLED EXTRUSION INTO (B)(6) FEMALE PATIENT'S MOUTH, TISSUE DISCOLORATION. ON (B)(4) 2014 RECEIVED A CALL IN RESPONSE TO THE RECALL LETTER OF SAID PRODUCT. THE PATIENT IS A STAFF MEMBER IN THE OFFICE. SHE SAID THAT THEY JUST RECEIVED THE GDPG AT THE BEGINNING OF MAY. SHE SAID THAT SHE WANTED TO SEE HOW IT WORKED SO SHE APPLIED SOME TO HERSELF ON THE CERVICAL OF #6. SHE DID NOT USE ANY ISOLATION. SHE SAID THAT IT CAME OUT IN THE UNCONTROLLED MANNER AND GOT ALL OVER HER GINGIVA. SHE SAID THAT SHE RINSED IT OFF IMMEDIATELY. SHE SAID THAT THE TISSUES TURNED WHITISH, BUT SHE HAD NO OTHER SYMPTOMS. SHE SAID THAT THE COLOR RETURNED TO NORMAL IN 2 DAYS AND SHE IS COMPLETELY RECOVERED. SHE DID NOT TAKE ANY MEDICATION OR RECEIVE ANY TREATMENT. ARRANGED FOR THE PICKUP AND REPLACEMENT. THIS IS A REPORTABLE MALFUNCTION ACCORDING TO 21 CFR 803.50 (A) (2) WHICH STATES THAT YOU MUST REPORT TO US NO LATER THAN 30 CALENDAR DAYS AFTER THE DAY THAT YOU RECEIVE OR OTHERWISE BECOME AWARE OF INFORMATION, FROM ANY SOURCE, THAT REASONABLY SUGGESTS THAT A DEVICE THAT YOU MARKET HAS MALFUNCTIONED AND THIS DEVICE OR A SIMILAR DEVICE THAT YOU MARKET WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, IF THE MALFUNCTION WERE TO RECUR. THIS IS A REPORTABLE MALFUNCTION AS THIS MALFUNCTION COULD CAUSE SERIOUS INJURY IF THE MATERIAL SHOOTS INTO THE PATIENT'S MOUTH OR OTHER AREAS OF THE BODY TO WHICH IT IS NOT INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350013 GLUMA DESENSITIZER POWER GEL VARNISH, CAVITY LBH HERAEUS KULZER GMBH 010103

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention