BEUDAMED
    FDA Adverse Event Summary report: N

    FUTURABOND DC SINGLEDOSE

    MDR report key: 2358327 · Received November 16, 2011

    Report

    Report Number
    8010908-2011-00001
    Date Received
    November 16, 2011
    Date of Event
    September 6, 2011
    Report Date
    September 9, 2011
    Manufacturer
    VOCO GMBH
    Product Code
    KLE
    PMA / PMN Number
    K070723
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON OUR INVESTIGATIONS WE ASSUME THAT THE PRODUCT WAS NOT FAULTY AT THE TIME OF APPLICATION. WE ATTRIBUTE THE FACT THAT THIS SURGERY HAS EXPERIENCED AN ACCUMULATION OF EVENTS INVOLVING LEAKAGE AND SQUIRTING OF MATERIAL TO UNFORTUNATE CIRCUMSTANCES AND TO PECULIARITIES IN THE APPLICATION OF THE MATERIAL. THESE CONDITIONS CANNOT BE RECONSTRUCTED BY US AND THEREFORE REMAIN BEYOND THE REACH OF OUR RISK CONTROL. THE INSTRUCTIONS FOR USE INDICATE CLEARLY THAT BLISTER PACKS SHOULD NOT BE ACTIVATED NEAR THE EYE AND THAT THE FOIL MUST NEITHER BE CREASED NOR DAMAGED WITH A FINGERNAIL. IN OUR VIEW, THE INSTRUCTIONS FOR USE CONTAIN SUFFICIENT CAUTIONARY ADVICE TO ASCERTAIN SECURE HANDLING OF THE PRODUCT. THERE ARE NO PLANS AT PRESENT TO IMPLEMENT ANY CORRECTIVE MEASURES.

    Description of Event or Problem · 1

    A DENTIST INFORMS US OF AN ADVERSE EVENT THAT OCCURRED DURING THE APPLICATION OF FUTURABOND DC SINGLEDOSE. THE DENTIST ADVISES THAT SOME OF THE CONTENT OF A SINGLEDOSE SPRAYED INTO HIS EYE WHEN HIS ASSISTANT ACTIVATED THE BLISTER WHILST THEY WERE WORKING ON A PATIENT. IN ACCORDANCE WITH THE CAUTIONARY NOTES IN OUR INSTRUCTIONS FOR USE HE HAD HIS EYE RINSED BY AN EYE SPECIALIST. HE INFORMS US THAT HE HAS RECENTLY HAD TROUBLE WITH THE RIGHT EYE. THE OIL GLAND IN HIS LOWER RIGHT EYE LID STOPPED FUNCTIONING, WHICH RESULTED IN A DRAINING INFECTION. IT WAS TREATED AND IS NOW HEALING. THE DENTIST SUSPECTS THAT OVERFILLING OF THE BLISTER PACK CAUSED THIS MALFUNCTION. THE DENTIST OBSERVED LEAKAGE DURING ACTIVATION OF A FURTHER 5 SINGLEDOSE BLISTERS FROM A TOTAL OF 3 PRODUCTION LOTS. THE DESCRIPTION OF THE PROBLEM REFERS TO THE APPLICATION OF THE SINGLEDOSE PACKAGING, NOT TO A PRODUCT PROBLEM RELATED TO A PRODUCTION LOT OR TO THE EFFECT OF THE PRODUCT ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUTURABOND DC SINGLEDOSE AGENT, TOOTH BONDING, RESIN KLE VOCO GMBH 1116385

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention