BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE PET BALLOON DILATORS

    MDR report key: 1010108 · Received March 10, 2008

    Report

    Report Number
    9710641-2008-00033
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Report Date
    February 20, 2008
    Manufacturer
    JUAREZ FACILITY
    Product Code
    KNQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE HAS NOT YET BEEN RECEIVED BY THE QA ENGINEER. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "(4) BALLOON USED DURING PROCEDURE AND EACH POPPED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE PET BALLOON DILATORS ESOPHAGEAL BALLOON DILATOR KNQ JUAREZ FACILITY 0708151

    Patients

    Seq Age Sex Outcome Treatment
    1 Other