BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNERVISION DETACHABLE TIPS

    MDR report key: 8577737 · Received May 2, 2019

    Report

    Report Number
    MW5086352
    Event Type
    Injury
    Date Received
    May 2, 2019
    Date of Event
    April 19, 2019
    Report Date
    April 30, 2019
    Manufacturer
    MEDOVATIONS / DIVERSATEK HEALTHCARE, INC.
    Product Code
    KNQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    RETAINED BOUGIE TIP REQUIRING SURGICAL INTERVENTION TO REMOVE DUE TO USING AGAINST MFR'S RECOMMENDATIONS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369526 INNERVISION DETACHABLE TIPS DILATOR, ESOPHAGEAL KNQ MEDOVATIONS / DIVERSATEK HEALTHCARE, INC. 50 FRENCH 16.6MM 222549

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention