BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAQUET SA

    MDR report key: 1888167 · Received October 15, 2010

    Report

    Report Number
    9710055-2010-00015
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    July 16, 2010
    Report Date
    September 14, 2010
    Manufacturer
    MAQUET S.A.
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET RECEIVED INFO CONCERNING THIS INCIDENT FROM THE HOSPITAL ATTORNEY. IT APPEARS THE ALLEGED BURN IS THE RESULT OF IR EXPOSURE, NOT PHYSICAL CONTACT WITH THE PRODUCT. THE ATTORNEY INDICATED THE LIGHT WAS APPROXIMATELY THREE OR FOUR FEET AWAY FROM PT AND BEHIND THE SURGEON'S HEAD DURING THE OPERATION. THE SURGEON DID NOT NOTICE ANY PROBLEM. THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. PRODUCT INFO PROVIDED BY THE HOSPITAL ATTORNEY DOES NOT MATCH ANY KNOWN MODEL OF MAQUET SURGICAL LIGHT. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HOSPITAL AND THE INVESTIGATION IS ON-GOING. SHOULD ADDITIONAL INFO BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED. MAQUET INC SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY. MAQUET S.A. PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT PT SUFFERED A SEVERE BURN INJURY TO BODY, CAUSING A COSMETIC DEFORMITY, PAIN AND SUFFERING. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET SA NONE FSY MAQUET S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other