BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISP BTN PENCIL W/ERBE PLG

    MDR report key: 4243976 · Received November 11, 2014

    Report

    Report Number
    1717344-2014-00979
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 15, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT: 11/11/2014. DATE OF FOLLOW-UP REPORT: 01/22/2015. EVALUATION OF THE INCIDENT DEVICE FOUND IT TO FUNCTION NORMALLY AND WITHIN SPECIFICATIONS. NO CONDITIONS WERE IDENTIFIED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE, IT HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE BEEN ASKED. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE ACTIVATED ON ITS OWN DURING A CAESARIAN PROCEDURE, RESULTING IN A LIGHT BURN TO THE PATIENT'S SKIN ON THE RIGHT SIDE OF THE BELLY. A TULLE GRAS TYPE DRESSING WAS APPLIED TO THE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726153 DISP BTN PENCIL W/ERBE PLG ES ACCESSORY GEI COVIDIEN LP VL2600E 1401066X

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR