BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUMA DESENSITIZER

    MDR report key: 5101424 · Received September 24, 2015

    Report

    Report Number
    9610902-2015-00014
    Event Type
    Injury
    Date Received
    September 24, 2015
    Date of Event
    September 2, 2015
    Report Date
    September 4, 2015
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    KLE
    PMA / PMN Number
    K962812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. EVALUATION SUMMARY: DIRECTIONS FOR USE INDICATE RUBBER DAM USE IS REQUIRED. THE OFFICE FAILED TO ENSURE ISOLATION, THEREBY GLUMA DESENSITIZER CAME INTO CONTACT WITH THE PATIENT'S SOFT TISSUE. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    BY WAY OF (B)(6), EMAIL FROM (B)(6) TERRITORY REP REGARDING HER HUSBAND, (B)(6), WHO HAD GLUMA DESENSITIZER PLACED DURING PROPHY APPOINTMENT ON #24,#25 RECESSION. WIFE/REP SENT PHOTOS, SHOWING DISCOLORED SOFT TISSUE. (B)(4) RESPONDED TO WIFE, I AM VERY SORRY TO HEAR OF HIS SITUATION. IS HE EXPERIENCING DISCOMFORT? WHAT WAS THE DATE OF HIS APPOINTMENT? HAS HE BEEN TREATED WITH ANYTHING ELSE TO TRY TO MITIGATE THE SYMPTOMS? DIRECTIONS FOR USE FOR GLUMA DESENSITIZER STATE "PROTECT MUCOUS MEMBRANES BY USING A RUBBER DAM. MAKE SURE THAT GLUMA DESENSITIZER ONLY COMES INTO CONTACT WITH AREA TO BE TREATED." THE PRODUCT IS CAUSTIC TO SOFT TISSUE AND CAN CAUSE CHEMICAL BURNS. FOR MEDICAL ADVICE, PLEASE REFER BACK TO YOUR DENTIST OR ANOTHER QUALIFIED MEDICAL PROVIDER. IF I MAY BE OF ASSISTANCE, DO NOT HESITATE TO CONTACT ME. WIFE RESPONDED THAT HUSBAND WAS IN A TON OF PAIN BUT HAD NOT BEEN TREATED WITH ANYTHING ELSE. (B)(4) LEFT MESSAGE AT DENTAL OFFICE ASKING FOR RETURN CALL, PREFERABLY FROM THE PRACTITIONER AND LEFT (B)(4)'S CONTACT INFORMATION. (B)(4) LM AGAIN FOR PRACTIONER TO RETURN CALL. (B)(4) THREE HOURS LATER, ADVISED WIFE/REP THAT THERE HAD BEEN NO RESPONSE FROM THE OFFICE. (B)(4) CALL FROM (B)(6) FROM OFFICE. PERSON WHO WORKED ON (B)(6) IS NOT DUE BACK UNTIL TOMORROW. (B)(6) WILL HAVE HER CALL ME THEN. (B)(4) NO FURTHER CONTACT WAS RECEIVED FROM OFFICE. THIS IS A SERIOUS INJURY (AS DEFINED IN 21 CFR SECTION 803.3) AS THE PATIENT REPORTED HAVING AN ADVERSE REACTION. BECAUSE THE MALFUNCTION ALLEGATION COULD NOT BE CONFIRMED, THE CAUSE OF THE ADVERSE REACTION COULD NOT BE DETERMINED. THIS INCIDENT WILL BE REPORTED TO MAINTAIN COMPLIANCE WITH 21 CFR 803 AND OUT OF AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633553 GLUMA DESENSITIZER AGENT, TOOTH BONDING, RESIN KLE HERAEUS KULZER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other