BEUDAMED
    FDA Adverse Event Other Summary report: N

    W&H WA-99LT 1:5 HIGH-SPEED ATTACHMENT

    MDR report key: 3059679 · Received April 11, 2013

    Report

    Report Number
    3015729-2013-00001
    Event Type
    Other
    Date Received
    April 11, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 9, 2013
    Manufacturer
    W&H DENTALWERK BURMOOS GMBH
    Product Code
    EFB
    PMA / PMN Number
    K070663
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    #(B)(4) WAS LAST REPAIRED (B)(4) 2008, #(B)(4) WAS LAST REPAIRED (B)(4) 2008. BOTH ATTACHMENTS ARE (B)(4). THERE ARE NOTES IN THE PREVIOUS REPAIRS THAT THERE WERE POSSIBLY GENERIC REPAIR PARTS IN THE ATTACHMENTS. GENERATION 1 HANDPIECE ATTACHMENTS ARE NO LONGER REPAIRED BUT ARE REPLACED WITH GENERATION 3 DEVICES. (B)(4).

    Description of Event or Problem · 1

    WHILE PERFORMING A DENTAL PROCEDURE, HANDPIECE ATTACHMENT OVERHEATED AND BURNED PATIENT. PATIENT WAS REFERRED TO A PLASTIC SURGEON FOR TREATMENT OF BURN ON TONGUE. THIS WAS THE FIRST PATIENT BURN REPORTED BY THE OFFICE, ORIGINALLY REPORTED (B)(4) 2012, BUT FOLLOW-UP TREATMENT WAS NOT INDICATED AT THAT TIME. SUBSEQUENTLY, A SECOND HANDPIECE ATTACHMENT, S/N (B)(4), BECAME THE CAUSE FOR THIS CURRENT EVENT. THE CURRENT EVENT WAS A BURNED LIP THAT DID NOT REQUIRE INTERVENTION OR FOLLOW-UP TREATMENT AND IS NOT DIRECTLY THE SUBJECT OF THIS REPORT; RATHER THE METHOD BY WHICH WE BECAME AWARE THE FIRST INCIDENT WAS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155214 W&H WA-99LT 1:5 HIGH-SPEED ATTACHMENT SPEED-INCREASING HANDPIECE ATTACHMENT EFB W&H DENTALWERK BURMOOS GMBH WA-99LT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention