BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXOGEN

    MDR report key: 1729104 · Received June 20, 2010

    Report

    Report Number
    1020279-2010-00173
    Event Type
    Injury
    Date Received
    June 20, 2010
    Date of Event
    April 20, 2010
    Report Date
    May 18, 2010
    Manufacturer
    BROOKS MANUFACTURING SITE
    Product Code
    LOF
    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.PRODUCT WILL NOT BE RETURNED FOR EVALUATION PURPOSES.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT A PATIENT DEVELOPED A BLISTER AT THE FACE OF THE TRANSDUCER. THE PATIENT EXPERIENCED SLIGHT PAIN. PER THE PRIMARY PHYSICIAN, THERE IS A RELATIONSHIP BETWEEN THE PATIENT'S SYMPTOM AND THE USE OF THE EXOGEN UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXOGEN BONE GROWTH STIMULATOR LOF BROOKS MANUFACTURING SITE

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention