BEUDAMED
    FDA Adverse Event Other Summary report: N

    GLUMA DESENSITIZER

    MDR report key: 2475557 · Received April 7, 2011

    Report

    Report Number
    9610902-2011-00001
    Event Type
    Other
    Date Received
    April 7, 2011
    Date of Event
    March 10, 2011
    Report Date
    April 6, 2011
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    KLE
    PMA / PMN Number
    K962812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE DID NOT CAUSE A SERIOUS INJURY, HOWEVER THE EVENT COULD HAVE CONTRIBUTED TO A SERIOUS INJURY. BASED ON THE INFO PROVIDED THERE WAS NO DETAIL PROVIDED WITH REGARDS TO ANY TYPE OF MEDICAL INTERVENTION TAKEN TO PRECLUDE PERMANENT DAMAGE. THE DEVICE WAS NOT RETURNED FOR EVAL. THE LABELING SPECIFICALLY INDICATES THE REQUIREMENT FOR EYE PROTECTION FOR THE USER AND PT. THE IRRITATION EXPERIENCED IS THE RESULT OF THE MEDICAL PROFESSIONAL ACCIDENTALLY DROPPING PRODUCT IN THE PT'S EYE. NECESSARY PRECAUTIONS TO PROTECT THE EYE WAS TAKEN BY THE DENTIST HOWEVER, IT WAS NOT SUFFICIENT.

    Description of Event or Problem · 1

    DENTAL OFFICE REP CALLED AND REPORTED THAT THEY GOT GLUMA DESENSITIZER IN A PT'S EYE. THEY HAD A MALE PT IN THE CHAIR AND SOME GLUMA DESENSITIZER SPLASHED A LITTLE BIT IN THE EYE. THEY RINSED HIS EYE WITH WATER, BUT HE SAID IT WAS STILL BURNING A BIT. ON (B)(6) 2011, THE PT WAS REPORTED TO BE OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUMA DESENSITIZER TOOTH RESIN BONDING AGENT KLE HERAEUS KULZER GMBH 65872354 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other