BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEDSTROEM-FILES, CC+

    MDR report key: 5316084 · Received September 29, 2004

    Report

    Report Number
    9611053-2004-00437
    Event Type
    Malfunction
    Date Received
    September 29, 2004
    Date of Event
    September 19, 2003
    Report Date
    August 30, 2004
    Manufacturer
    VDW GMBH
    Product Code
    EIY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    IN THIS INCIDENT THERE WAS A REPORT OF INJURY TO THE PT. HOWEVER, AS A RESULT OF THIS MALFUNCTION, THE POTENTIAL FOR SURGICAL INTERVENTION EXISTS (THOUGH INADVISABLE PER EXPERT OPINION PROVIDED BY DR. (B)(6), DATED (B)(6) 2002) TO PRECLUDE INJURY OR ILLNESS THAT WOULD NECESSITATE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION AS EVIDENCED BY PREVIOUS REPORTED EVENTS. THIS EVENT, THEREFORE, IS REPORTABLE PER 21CFR PART 803.

    Description of Event or Problem · 1

    THE DENTIST REPORTED SEPARATING A FILE IN THE PT'S TOOTH DURING A DENTAL PROCEDURE AND ELECTED TO FILL AROUND THE FILE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEDSTROEM-FILES, CC+ DENTAL FILE EIY VDW GMBH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1