BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREATHTEK UBT

    MDR report key: 13930298 · Received March 28, 2022

    Report

    Report Number
    1524213-2022-00003
    Event Type
    Injury
    Date Received
    March 28, 2022
    Date of Event
    February 28, 2022
    Report Date
    March 28, 2022
    Manufacturer
    MERIDIAN BIOSCIENCE INC.
    Product Code
    OZA
    UDI-DI
    00840733101434
    PMA / PMN Number
    P100025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    PATIENT REPORTED COMPLICATIONS AFTER DRINKING PRANACTIN-CITRIC SOLUTION. PATIENT SAID SHE HAD "BUBBLE GUTS" FOR 20 MINUTES AFTER DRINKING SOLUTION AND THEN DID NOT PRODUCT STOOL FOR 4 DAYS AFTER. PATIENT REPORTED COMPLICATIONS AFTER DRINKING PRANACTIN-CITRIC SOLUTION. PATIENT SAID SHE HAD "BUBBLE GUTS" FOR 20 MINUTES AFTER DRINKING SOLUTION AND THEN DID NOT PRODUCT STOOL FOR 4 DAYS AFTER. THE PRODUCT LABELING INCLUDES A PRECAUTIONARY STATEMENT REGARDING THAT THOSE WHO ARE HYPERSENSITIVE TO MANNITOL SHOULD AVOID TAKING THE DRUG SOLUTION. HYPERSENSITIVITY IS A KNOWN REACTION THAT IS ALSO IDENTIFIED WITHIN THE LABELINGS POST-MARKETING EXPERIENCES SECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321115 BREATHTEK UBT BREATHTEK UBT OZA MERIDIAN BIOSCIENCE INC. 01 453K05L 00840733101434

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female