BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXOGEN COUPLING GEL

    MDR report key: 1733160 · Received June 23, 2010

    Report

    Report Number
    1020279-2010-00168
    Event Type
    Injury
    Date Received
    June 23, 2010
    Date of Event
    June 1, 2009
    Report Date
    May 18, 2010
    Manufacturer
    BROOKS MANUFACTURING SITE
    Product Code
    MUI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW, INC. IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED UPON INFORMATION WHICH SMITH & NEPHEW, INC. HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW, INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT.LOT NUMBER OF THE COUPLING GEL WAS NOT PROVIDED BY THE CUSTOMER.PRODUCT WILL NOT BE RETURNED FOR EVALUATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RASH APPEARED BY THE SITE OF THE ULTRASOUND GEL AREA. THE TREATMENT OF THE UNIT WAS DISCONTINUED. THE PATIENT REPORTED THE SKIN REACTION IN THE HOSPITAL AND THE SKIN HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXOGEN COUPLING GEL ULTRASOUND COUPLING GEL MUI BROOKS MANUFACTURING SITE OR81025200 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention