BEUDAMED
    FDA Adverse Event Other Summary report: N

    GLUMA DESENSITIZER

    MDR report key: 1628604 · Received March 4, 2010

    Report

    Report Number
    9610902-2010-00002
    Event Type
    Other
    Date Received
    March 4, 2010
    Date of Event
    December 9, 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 Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER FURTHER REVIEW IT WAS DETERMINED THAT THIS TYPE OF INCIDENT IS REPORTABLE BECAUSE A SERIOUS INJURY COULD HAVE RESULTED. 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

    (B)(6) FROM DR. (B)(6)'S OFFICE CALLED. SHE HAD A 30ISH, MALE, PT, TODAY THAT GOT GLUMA DESENSITIZER IN HIS EYE. SHE SAID THAT SHE PUT THE GLUMA DESENSITIZER ON AN APPLICATOR TIP AND WAS HANDING IT ACROSS TO THE DOCTOR. THE APPLICATOR TIP SNAGGED ON HER GLOVE AND FLICKED A DROP INTO THE PT'S EYE. I ASKED IF THE PT WAS WEARING GLASSES OR GOGGLES AND HE WAS NOT. I ASKED WHAT THEY DID NEXT. SHE SAID THEY FLUSHED THE PT'S EYES WITH LOTS OF WATER AND SALINE SOLUTION, LIKE CONTACT LENS CLEANER. I ASKED IF THE PT HAS SEEN HIS MEDICAL DOCTOR AND SHE SAID THEY TRIED TO GET HIM IN TO SEE HIS OPHTHALMOLOGIST BUT THE DOCTOR WAS NOT IN TODAY. THEY DID RECOMMEND HE SEE A MEDICAL DOCTOR. I ASKED IF THE PT WAS GIVEN ANY MEDICATION BY THE DENTIST AND HE WAS NOT. I ASKED HOW THE PT'S COMFORT LEVEL WAS WHEN HE LEFT THE OFFICE AND WAS TOLD HIS EYE STILL HURT. (B)(6) SAID THE PT SAID IT HURT UP HIGH IN HIS EYE WHERE THEY COULD NOT REACH BY FLUSHING WITH WATER. I ASKED IF THE PT HAS ANY FOLLOW UP SCHEDULED AND WAS TOLD THE DENTIST IS GOING TO CALL HIM TONIGHT TO CHECK ON HIS STATUS AND SEE IF HE WAS SEEN BY A MEDICAL DOCTOR. AS OF (B)(6) 2009, PT STATUS FOLLOW UP WITH DENTIST, PT SAW AND EYE DOCTOR FOR FLUSHING OF THE EYE AND PT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUMA DESENSITIZER TOOTH RESIN BONDING AGENT KLE HERAEUS KULZER GMBH 65872354 020089

    Patients

    Seq Age Sex Outcome Treatment
    1 Other