BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIPWIRE HYDROPHILIC GUIDEWIRE

    MDR report key: 4805632 · Received May 27, 2015

    Report

    Report Number
    2126666-2015-00024
    Event Type
    Injury
    Date Received
    May 27, 2015
    Manufacturer
    LAKE REGION MFG., INC.
    Product Code
    DQX
    PMA / PMN Number
    K000011
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE, NO PHYSICAL ANALYSIS OF THE PRODUCT CAN BE PERFORMED. THE MFG BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND INSPECTION SPECIFICATIONS. IT WAS REPORTED THAT NO PRODUCT IS EXPECTED TO BE RETURNED FOR EVAL. SHOULD ANY FURTHER RELEVANT INFO BECOME AVAILABLE, A FOLLOW UP MEDWATCH REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    MW REF # 5040084.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343302 ZIPWIRE HYDROPHILIC GUIDEWIRE DQX LAKE REGION MFG., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1