BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDGE CT PEN BUTTON HLSTR GAYLD

    MDR report key: 3240572 · Received July 16, 2013

    Report

    Report Number
    1717344-2013-00441
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 20, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT SAMPLE WAS NOT RETURNED 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 PENCIL BUTTON GOT STUCK AND WHEN THEY PUT THE PENCIL IN THE HOLSTER, IT REMAINED ON AND HOT. IT MELTED THE PLASTIC HOLSTER. NO INJURIES WERE REPORTED. THE INCIDENT SAMPLE IS NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330324 EDGE CT PEN BUTTON HLSTR GAYLD ES ACCESSORY, NON-STERILE GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK