BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNEA

    MDR report key: 2581655 · Received April 10, 2012

    Report

    Report Number
    9681479-2012-00001
    Event Type
    Other
    Date Received
    April 10, 2012
    Date of Event
    March 30, 2012
    Report Date
    April 9, 2012
    Manufacturer
    W & H DENTALWERK BURMOOS GMBH
    Product Code
    EFB
    PMA / PMN Number
    K070663
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ALL GEN 1 WA-99LT DEVICES RETURNED FOR REPAIR ARE SUBJECT TO UPGRADE TO GEN 3 WA-99LT VERSION. GEN 3 DEVICES INCORPORATE A CERAMIC BALL UNDER THE PUSH-BUTTON HEADCAP THAT REDUCES THE RISK OF BURN DUE TO UNINTENDED HEADCAP ACTIVATION DURING PROCEDURE. NO GEN 1 DEVICES ARE REPAIRED AND IF UPGRADE IS DECLINED THE HANDPIECE ATTACHMENT IS RETURNED WITH A WARNING STICKER ATTACHED TO THE DEVICE THAT STATES "DO NOT USE, MAY CAUSE PT INJURY." IN ADDITION, A "DEAR DOCTOR & STAFF" LETTER IS SENT WITH THE UNREPAIRED DEVICE ADVISING THEM OF THE RELEVANT FDA ALERT INFO ON 1:5 SPEED-INCREASING HANDPIECE ATTACHMENTS AND THE PT BURN HAZARD RELATED TO IMPROPERLY MAINTAINED OR OTHERWISE MISUSED DEVICES. THE SUBJECT HANDPIECE ATTACHMENT WAS RETURNED IN THIS CAUTIONARY STATE APPROX 2 WEEKS PRIOR TO THE REPORTED INCIDENT AFTER THE DENTAL OFFICE DECLINED THE UPGRADE. THE DEVICE SHOULD NOT HAVE BEEN USED AND THE PT WAS INJURED IN SPITE OF THE HAZARD WARNING.

    Description of Event or Problem · 1

    IN THE COURSE OF DENTAL TREATMENT, USING A 1:5 GEAR-DRIVEN HANDPIECE ATTACHMENT, THE PT RECEIVED AN INTRAORAL BURN. THE REPORTED STATEMENT FROM THE DENTAL HEALTHCARE PROVIDER STATED "PT BURNED. PT HAS BEEN TO A BURN SPECIALIST." THE OFFICE WAS CONTACTED AS A FOLLOW-UP INVESTIGATION TO CONFIRM THE REFERRAL, AND DR (B)(6) INDICATED THE PT WAS REFERRED TO A PLASTIC SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNEA 1:5 GEAR-DRIVEN HANDPIECE ATTACHMENT EFB W & H DENTALWERK BURMOOS GMBH WA-99LT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention