BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAINTENANCE STATION FOR ELECTRIC PEN DRIVE

    MDR report key: 3203120 · Received July 2, 2013

    Report

    Report Number
    8030965-2013-04229
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    DZI
    PMA / PMN Number
    K043310
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. CORRECTED DATA: UPON FURTHER REVIEW OF THE COMPLAINT, IT WAS DETERMINED THE COMPLAINT IS NOT REPORTABLE DUE TO THE COMPLAINT NOT MEETING THE DEFINITION OF AN MDR REPORTABLE EVENT. NOT LIKELY TO RESULT IN PATIENT HARM OR THE NEED FOR ADDITIONAL MEDICAL OR SURGICAL INTERVENTION. THIS DOES NOT MEET THE DEFINITION OF A REPORTABLE EVENT. SYNTHES IS RETRACTING MEDWATCH REPORT #: 8030965-2013-04229.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    FACILITY REPORTS THE MAINTENANCE STATION OF PEN DRIVE IS VERY LOUD AND SHOWS AN ERROR WHEN OPERATING. IT IS NOT REPORTED HOW THIS ISSUE WAS DISCOVERED, NO ADDITIONAL INFORMATION WAS REPORTED. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302702 MAINTENANCE STATION FOR ELECTRIC PEN DRIVE DZI SYNTHES GMBH 0922

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention