BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALLEN EASY LOCK BLADE CLAMP

    MDR report key: 1381891 · Received May 13, 2009

    Report

    Report Number
    1221538-2009-00004
    Event Type
    Other
    Date Received
    May 13, 2009
    Date of Event
    April 8, 2009
    Report Date
    May 13, 2009
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    HXD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SALES REP VISITED THE FACILITY IMMEDIATELY AFTER THE INCIDENT. DURING THAT VISIT, THE REP WITNESSED THE USERS INSTALL THE RAIL CLAMPS IN SUCH A WAY THAT DAMAGE TO THE UNITS OR A FAILURE COULD RESULT DURING USE. IN-SERVICE DEVICE INSTRUCTIONS AND CORRECTIVE TRAINING WERE BOTH PROVIDED. ALLEN HAS BEEN NOTIFIED THAT THE DAMAGE CLAMP WILL NOT BE RETURNED FOR OUR EVALUATION BUT MAY BE EVALUATED AT THEIR FACILITY. AT THIS TIME, THERE ARE NO PLANS TO DO AN ENGINEERING EVALUATION IN THE FIELD. THIS INCIDENT IS BEING REPORTED IN RESPONSE TO A MEDWATCH REPORT COMPLETED BY THE USER FACILITY.

    Description of Event or Problem · 1

    ON (B)(6), 2009, AN ALLEN SALES REP WAS CONTACTED BY A CUSTOMER REPORTING A NON-INJURY INCIDENT INVOLVING AN ALLEN CAMP. A WRITTEN REPORT FROM THE HOSPITAL FOLLOWED AND WAS RECEIVED BY ALLEN ON (B)(6). ACCORDING TO THE REPORT, THE INCIDENT OCCURRED AFTER THE COMPLETION OF THE PROCEDURE, WHEN THE CLAMP CAME FREE FROM THE TABLE RAIL. THE PATIENT WAS STILL ON THE TABLE AT THE TIME BUT NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEN EASY LOCK BLADE CLAMP EASY LOCK BLADE CLAMP HXD ALLEN MEDICAL SYSTEMS A-40040-A2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK