BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE(TM) BALLOON DILATATION CATHETER

    MDR report key: 6980478 · Received October 26, 2017

    Report

    Report Number
    3005099803-2017-03292
    Event Type
    Malfunction
    Date Received
    October 26, 2017
    Report Date
    October 1, 2017
    Product Code
    KOG
    PMA / PMN Number
    K974788
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OF THE 2 EVENTS REPORTED UNDER EXEMPTION NUMBER E2012015, 1 COMPLAINT DEVICE WAS DISPOSED AND 1 COMPLAINT DEVICE WAS NOT RETURNED.

    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 2 REPORTED EVENT OF BALLOONS BURSTS/PINHOLES. ALL PATIENT DEMOGRAPHIC INFORMATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761167 CRE(TM) BALLOON DILATATION CATHETER ENDOSCOPE AND/OR ACCESSORIES, DILATOR, ESOPHAGEAL KOG UNK99

    Patients

    Seq Age Sex Outcome Treatment
    1