BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHRONOS INJ 10 CC I/MIX+APPLIC-CARTRIDGE

    MDR report key: 3212272 · Received July 9, 2013

    Report

    Report Number
    8030965-2013-04183
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 31, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    MQV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2013, REPORTEDLY THE SYRINGE ATTACHMENT ON THE GUN HANDLE BROKE DURING INJECTION. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS 1 OF 1 REPORT FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314087 CHRONOS INJ 10 CC I/MIX+APPLIC-CARTRIDGE MQV SYNTHES GMBH 8059667

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR