BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK V. MUELLER

    MDR report key: 3701310 · Received March 26, 2014

    Report

    Report Number
    1038548-2014-00035
    Event Type
    Injury
    Date Received
    March 26, 2014
    Date of Event
    December 1, 2013
    Report Date
    March 26, 2014
    Manufacturer
    CAREFUSION
    Product Code
    FDG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). PER EMAIL FROM THE CUSTOMER 18 (B)(6) 2014. THIS WAS A DUPLICATE OF REPORTABLE COMPLAINT (B)(4)(1038548-2013-00033). PLEASE BE INFORMED THAT THIS COMPLAINT WILL BE CLOSED OUT IN OUR SYSTEM AS A DUPLICATE.

    Description of Event or Problem · 1

    BURN MAUDE REPORT # (B)(4) WAS RECEIVED 05 MARCH 2014. THE REPORT STATES: "AT TEBBETTS LIGHTED BREAST RETRACTOR WAS BEING USED DURING BREAST SURGERY. THE LIGHT SOURCE A LUXTEX MLX BY INTEGRA WAS RUNNING WITH THE LIGHT SOURCE AT 100% THROUGHOUT THE CASE. THE RETRACTOR WAS MOVED FROM THE MAYO STAND ONTO THE PATIENTS DIRECT SKIN. AN APPROXIMATELY 4CM BURN DEVELOPED INFERIOR TO THE RIGHT BREAST, APPEARING LIGHT PINK IN COLOR. OINTMENT AND A WOUND DRESSING WERE APPLIED TO THE AREA. DURING A FOLLOW-UP APPOINTMENT, ANOTHER WOUND DRESSING WAS APPLIED. THE PROCEDURE WAS A BILATERAL SILICONE PERMANENT BREAST IMPLANT WITH THE REMOVAL OF SOFT TISSUE EXPANDERS. THE PATIENT WAS A (B)(6) OLD FEMALE PATIENT, (B)(6) WITH AN ALLERGY TO ADHESIVE BANDAGE. THE TWO TEBBETTS RETRACTORS THAT WERE LISTED WERE 88-1087 AND 88-1088.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178869 UNK V. MUELLER RETRACTOR, FIBEROPTIC FDG CAREFUSION UNK V. MUELLER

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other