BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUMA DESENSITIZER POWERGEL

    MDR report key: 2901040 · Received December 19, 2012

    Report

    Report Number
    9610902-2012-00161
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    October 30, 2012
    Report Date
    December 5, 2012
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    LBH
    PMA / PMN Number
    K093575
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AS ALLOWED BY EXEMPTION# (B)(4), HERAEUS KULZER LLC (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HERAEUS KULZER (B)(4) (THE MFR). ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE'RE REPORTING IT OUT OF CAUTION TO BE COMPLIANT WITH 21 CFR PART 803. THIS PRODUCT IS SOLD IN THE US UNDER THE CATALOG #66043451. CONCLUSION: FROM THE ACCIDENT AND THE UNFORTUNATE COMBINATION OF CIRCUMSTANCES CAN DERIVE NO IMMEDIATE CORRECTIVE ACTION, ESPECIALLY BECAUSE THE GEL USED HERE, THE LOCAL RISKS OF CHEMICAL BURNS AND THE RISK OF SPLASHING HAVE BEEN MINIMIZED COMPARED TO CONVENTIONAL LIQUID DOSAGE FORM.

    Description of Event or Problem · 1

    HKG REP WAS NOTIFIED OF THE INCIDENT WITH GLUMA DESENSITIZER. DENTAL ASSISTANT TRAINEE ACCIDENTALLY GOT GLUMA DESENSITIZER POWERGEL INTO HER LEFT EYE WHILE REMOVING THE APPLICATOR TIP AND CLEANING THE SYRINGE. THE EYE WAS IMMEDIATELY RINSED WITH WATER AND EXAMINED BY A GENERAL PRACTITIONER AND AN OPHTHALMOLOGIST. THE EYE BECAME SEVERELY SWOLLEN 18 HOURS AFTER INCIDENT AND THE OPHTHALMOLOGIST DIAGNOSED WITH A MILD CHEMICAL BURN TO THE CONJUNCTIVA AND CORNEA. THE PT RECEIVED MEDICAL TREATMENT BY THE OPHTHALMOLOGIST. SHE WAS PRESCRIBED BEPANTHEN EYE OINTMENT AND A CORTISONE (OR ANTIBIOTICS) OINTMENT. VISION WAS IMPAIRED 14 DAYS AND THE SWELLING LASTED FOR 4-6 WEEKS. THE ASSISTANT WAS NOT WEARING EYE PROTECTION WHEN THE INCIDENT OCCURRED. THE PT IS NO LONGER TAKING MEDICATION FOR THE SYMPTOMS AND THE SWELLING IS NOW COMPLETELY GONE. VISION HAS RETURNED TO 100% FOR THE ASSISTANT; HOWEVER, THERE REMAINS A SMALL RED SPOT ON THE CORNEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUMA DESENSITIZER POWERGEL LBH VERNISH, CAVITY LBH HERAEUS KULZER GMBH 010032

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention