BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-02354

    MDR report key: 3092490 · Received May 3, 2013

    Report

    Report Number
    2520274-2013-02354
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 9, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Description of Event or Problem · 1

    ON AN UNKNOWN DATE, A PATIENT DEVELOPED AN INFECTION AT THE SURGICAL SITE. THE SURGERY HAD BEEN PERFORMED TWO WEEKS PRIOR FOR A RIB FRACTURE AND CHEST WALL STABILIZATION. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN UNKNOWN RIB FRACTURE AND CHEST WALL STABILIZATION PRODUCT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194513 HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention