BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MANOMETRY

    MDR report key: 12967696 · Received December 9, 2021

    Report

    Report Number
    3005344223-2021-00002
    Event Type
    Injury
    Date Received
    December 9, 2021
    Date of Event
    November 16, 2021
    Report Date
    December 9, 2021
    Manufacturer
    GIVEN IMAGING LOS ANGELES LLC
    Product Code
    FFX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, THEY HAD AN ANORECTAL STUDY WHERE THE BALLOON DETACHED AND THE BALLOON WAS LEFT IN THE PATIENTS BODY AND HAD TO BE REMOVED WITH AN ENEMA. THEY USED THE UNWAXED DENTAL FLOSS TO TIE IT ON AND THAT THIS IS A KNOWN ISSUE. THEY ARE AWARE AND MANY CUSTOMER USED WAXED DENTAL FLOSS AS IT HOLDS BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1867913 UNKNOWN MANOMETRY FFX GIVEN IMAGING LOS ANGELES LLC UNKNOWN MANOMETRY

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention