BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PILLING RING BLADE RIGHT #2

    MDR report key: 1732984 · Received June 4, 2010

    Report

    Report Number
    1044475-2010-00059
    Event Type
    Malfunction
    Date Received
    June 4, 2010
    Date of Event
    April 12, 2010
    Report Date
    May 10, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KBN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, THE DEVICE SAMPLE WAS NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    A MEDWATCH WAS RECEIVED FOR THIS DEVICE. THE CUSTOMER REPORTS THAT THE MOUTH GAG WAS PLACED IN THE PT'S MOUTH FOR A SURGICAL PROCEDURE. THE INSTRUMENT SNAPPED APART WHILE STILL IN THE PT'S MOUTH. THE PT'S MOUTH CLOSED. THE DOCTOR EXAMINED THE PT'S TEETH AND MOUTH AND THERE WAS NO INJURY NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PILLING RING BLADE RIGHT #2 MOUTH GAG KBN TELEFLEX MEDICAL 764PG NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1