BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLOON MINI ONE BUTTON

    MDR report key: 5046498 · Received August 7, 2015

    Report

    Report Number
    1526012-2015-00004
    Event Type
    Malfunction
    Date Received
    August 7, 2015
    Date of Event
    June 6, 2015
    Report Date
    June 11, 2015
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    PMA / PMN Number
    K945618
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE PROVIDED INFORMATION, THE INCIDENT IS NOT A REPORTABLE EVENT PER 21 CFR SECTION 803. THERE WAS NO DEATH. THERE WAS NO SERIOUS INJURY, AS DEFINED BY THE FDA. THIS WAS NOT LIFE-THREATENING, NOR DID THIS RESULT IN PERMANENT IMPAIRMENT OR NECESSITATE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT. THERE WAS A DISCREPANCY IN THE INITIAL REPORT. THE EVENT DESCRIPTION STATES THE DEVICE WAS 1.5CM IN LENGTH, BUT THE CATALOG NUMBER/BRAND NAME SAYS IT WAS 1.2CM. THE EXACT LENGTH OF THE DEVICE IS UNCLEAR AND IT IS POSSIBLE THAT THE INCORRECT SIZE DEVICE WAS USED. SEVERAL ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION AND CLARIFY THIS DISCREPANCY. THE DEVICE WAS NOT RETURNED FOR INSPECTION, SO AN ANALYSIS OF THE DEVICE COULD NOT BE PERFORMED. THE LOT NUMBER PROVIDED IS NOT A VALID LOT NUMBER FOR THIS DEVICE, SO A DHR REVIEW COULD NOT BE COMPLETED. BALLOON BUTTONS MAY BECOME DISPLACED DUE TO EXCESSIVE FORCE OR PRESSURE. THE ASYMMETRIC BALLOON IS BELIEVED TO BE THE RESULT OF THE BALLOON BEING DISPLACED WHILE INFLATED, RATHER THAN THE CAUSE OF DISLODGEMENT. WE WILL PROVIDE ADDITIONAL INFORMATION TO THE FDA IF THE DEVICE OR ADDITIONAL INFORMATION IS ABLE TO BE OBTAINED AND ITS ANALYSIS CHANGES THE CONCLUSION OF THIS REPORT. WE HAVE ASSIGNED (B)(4) TO THIS REPORT.

    Description of Event or Problem · 1

    VOL REF NO # MW5043179.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521738 BALLOON MINI ONE BUTTON TUBES, GASTROINTESTINAL KNT APPLIED MEDICAL TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1