BEUDAMED
    FDA Adverse Event Other Summary report: N

    GLUMA DESENSITIZER

    MDR report key: 1628602 · Received March 4, 2010

    Report

    Report Number
    9610902-2010-00001
    Event Type
    Other
    Date Received
    March 4, 2010
    Date of Event
    November 19, 2009
    Report Date
    February 23, 2010
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    KLE
    PMA / PMN Number
    K962812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 EVALUATION. THE LABELING SPECIFICALLY INDICATES THE REQUIREMENT FOR EYE PROTECTION FOR THE USER AND PT. THE INJURY EXPERIENCED IS A RESULT OF THE DENTIST DROPPING PRODUCT IN PT'S EYE. NECESSARY PRECAUTIONS TO PROTECT THE EYE WAS NOT TAKEN BY THE DENTIST.

    Description of Event or Problem · 1

    RECEIVED CALL FROM DR. (B)(6)'S OFFICE. THEY SAID THEY HAD A PT IN THEIR OFFICE THAT HAD SEEN HER DENTIST AND THE ASSISTANT HAD GOTTEN A DROP OF THE GLUMA IN HER EYE. REQUESTED THE DENTIST PHONE NUMBER, THE PT'S GENDER AND AGE. THE PT WAS PUT ON THE PHONE AND PROVIDED HER DENTIST INFO. SHE WAS ASKED TO DESCRIBE HER SYMPTOMS. SHE SAID SHE HAD REDNESS AND IRRITATION IN THE LEFT EYE. ASKED IF SHE WAS TAKING ANY MEDICATION. SHE SAID SHE WAS AT THE OFFICE TO GET A PRESCRIPTION AND ANY OTHER TREATMENT. THE PT'S DENTIST, DR. (B)(6) WAS CONTACTED FOR DETAILS. SARA ACKNOWLEDGED THAT SHE WAS AWARE OF THE SITUATION. THE PT WAS IN FOR A FILLING AND THE ASSISTANT HAD ACCIDENTLY GOT SOME GLUMA IN THE PT'S EYE. THE ASSISTANT STOPPED WHAT HE WAS DOING AND EXPLAINED TO THE PT WHAT HAD HAPPENED. THE PT WAS FINE AND THEY FINISHED THE PROCEDURE. THE PT CALLED HER DENTIST ON (B)(6) 2009, REQUESTING DETAILS BECAUSE SHE HAD REDNESS AND IRRITATION AND WAS GOING TO HER DOCTOR'S OFFICE FOR THEM TO LOOK AT IT. THE ACCIDENT OCCURRED DURING A 2 SURFACE FILLING ON TEETH #31. THE PT WAS INFORMED TO RINSE HER EYE AT HOME AND WAS NOT TOLD TO RINSE WHEN THE ACCIDENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUMA DESENSITIZER TOOTH RESIN BONDING AGENT KLE HERAEUS KULZER GMBH 65872354 010082

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other