BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY

    MDR report key: 18318588 · Received December 13, 2023

    Report

    Report Number
    3025300237-2023-00001
    Event Type
    Injury
    Date Received
    December 13, 2023
    Report Date
    October 27, 2023
    Manufacturer
    HOPE MEDICAL
    Product Code
    KCF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. THE DOCTOR DID NOT MAKE A REPORT TO BRYAN MEDICAL OF THE PRODUCT BEING FAULTY. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED, BUT IS ASSUMED TO BE INCORRECT SELECTION OF BALLOON SIZE.

    Description of Event or Problem · 0

    INFINITY BALLOON WAS USED ON A PATIENT WITH THE INTENTION OF DILATING THE ESOPHAGUS. UPON INSERTION THE PHYSICIAN PUNCTURED THE PATIENT'S ESOPHAGUS AND LEFT TEARING OF ESOPHAGEAL TISSUE. THE PATIENT WAS KEPT IN THE HOSPITAL FOR OBSERVATION FOR 3 DAYS AFTER WHICH THEY WERE DETERMINED TO BE FINE OK AND WERE RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327070 INFINITY DILATION CATHETER KCF HOPE MEDICAL UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization