BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-02807

    MDR report key: 3130624 · Received May 24, 2013

    Report

    Report Number
    2520274-2013-02807
    Event Type
    Injury
    Date Received
    May 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN ASSISTANT

    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.

    Description of Event or Problem · 1

    A PHYSICIAN ASSISTANT REPORTED THAT HE HAD WITNESSED A PATIENT INFECTION WITH CHRONOS STRIPS ON AN UNKNOWN DATE. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232429 MQV SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention