BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE(TM) BALLOON DILATATION CATHETER

    MDR report key: 7464212 · Received April 26, 2018

    Report

    Report Number
    3005099803-2018-01394
    Event Type
    Malfunction
    Date Received
    April 26, 2018
    Report Date
    March 31, 2018
    Product Code
    KOG
    PMA / PMN Number
    K974788
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOR THE 1 EVENT REPORTED UNDER EXEMPTION NUMBER E2012015, THE DEVICE WAS DISPOSED. (B)(4).

    Description of Event or Problem · 1

    THE MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER E2012015 FOR PRODUCT CODE KOG. THIS REPORT COVERS 1 REPORTED EVENT OF BALLOON BURST. ALL DEMOGRAPHIC INFORMATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308326 CRE(TM) BALLOON DILATATION CATHETER ENDOSCOPE AND/OR ACCESSORIES, DILATOR, ESOPHAGEAL KOG UNK99

    Patients

    Seq Age Sex Outcome Treatment
    1