BEUDAMED
    FDA Adverse Event Other Summary report: N

    GLUMA DESENSTIZER

    MDR report key: 3118614 · Received April 10, 2013

    Report

    Report Number
    9610902-2013-00041
    Event Type
    Other
    Date Received
    April 10, 2013
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    KLE
    PMA / PMN Number
    K962812
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    AS ALLOWED BY (B)(4), (B)(4) (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. TYPE OF REPORTABLE EVENT. THE DENTAL OFFICE DID NOT REPORT IF ANY INJURY OCCURRED DUE TO THE INCIDENT; WE'RE REPORTING TO BE COMPLIANT WITH 21 CFR PART 803. CONCLUSIONS: THE DIRECTIONS FOR US STATE, "RISK OF SERIOUS DAMAGE EYES. IN CASE OF CONTACT WITH EYES, RINSE IMMEDIATELY WITH PLENTY OF WATER AND SEEK MEDICAL ADVICE. BEFORE USE, PUT ON THE PROTECTIVE GOGGLES AND COVER THE PATIENT'S EYES TO PROTECT AGAINST SPLASHES OF MATERIAL." THE RISK OF EYE INJURY AND PROTECTIVE MEASURES ARE CLEARLY STATED IN THE DIRECTIONS. DUE TO THE AFOREMENTIONED REASONS NO FURTHER ACTION IS DEEMED NECESSARY AT THIS TIME. THE INVESTIGATION IS CLOSED. CAPA MEASURES ARE NOT PROPOSED OR INITIATED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152029 GLUMA DESENSTIZER KLE TOOTH RESIN BONDING AGENT KLE HERAEUS KULZER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1