BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK V. MUELLER

    MDR report key: 3701353 · Received March 26, 2014

    Report

    Report Number
    1038548-2014-00037
    Event Type
    Injury
    Date Received
    March 26, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 26, 2014
    Manufacturer
    CAREFUSION
    Product Code
    FDG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP EMDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BURN . 'A LITTLE BOY WAS RECENTLY BURNED WHEN USING SEVERAL DIFFERENT TEBBETTS RETRACTORS. THE CUSTOMER SAYS THAT THE LIGHT SOURCE CONNECTION HAS BEEN HOT AT THE LIGHT SOURCE AND BURNING THE DRAPES FOR ABOUT A MONTH. THEY HAVE BEEN USING A LIGHT CORD THAT HAS CRACKS IN THE INSULATION. CUSTOMER WAS TOLD TO STOP USING ANY LIGHT CORD THAT HAS CRACKS IN THE INSULATION @ THAT THEY NEED TO USE A COMPATIBLE LIGHT CORD WHICH (B)(6) VERIFIED. THEY HAVE BEEN USING 88-9727 - LIGHT CORD 5MM, LIGHT SOURCE : LUXTEC, THEY USE TEBBETTS RETRACTORS 88-1187, 88-1088 MOVING FORWARD, THEY WILL USE COMPATIBLE LIGHT CORD 88-9760 - 3.5MM CABLE': ADDITIONAL INFORMATION RECEIVED FROM THE SALES REP (B)(4) 2014. IT WAS REPORTED THAT THE CUSTOMER STATED THAT THE TEBBETTS RETRACTORS ARE OK AND THEY ARE JUST GETTING HOT CAUSE THEY WERE USING A CODD THAT WAS DELIVERING TOO MUCH ENERGY. WE WILL NOT BE RECEIVING THE INSTRUMENTS FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178718 UNK V. MUELLER RETRACTOR, FIBEROPTIC FDG CAREFUSION UNK V. MUELLER

    Patients

    Seq Age Sex Outcome Treatment
    1 Other